Journal articles: 'Grant University'

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Kabo, Felichism W., and George A. Mashour. "Effect of a Clinical and Translational Science Award institute on grant funding in a major research university." Journal of Clinical and Translational Science 1, no. 2 (2017): 88–93. http://dx.doi.org/10.1017/cts.2016.32.

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IntroductionPrevious studies have examined the impact of Clinical and Translational Science Awards programs on other outcomes, but not on grant seeking. The authors examined the effects on grant seeking of the Michigan Institute for Clinical & Health Research (MICHR), a Clinical and Translational Science Awards institute at the University of Michigan.MethodsWe assessed over 63,000 grant proposals submitted at the University of Michigan in the years 2002–2012 using data from the university and MICHR’s Tracking Metrics and Reporting System. We used a retrospective, observational study of the dynamics of grant-seeking success and award funding. Heckman selection models were run to assess MICHR’s relationship with a proposal’s success (selection), and subsequently the award’s size (outcome). Models were run for all proposals and for clinical and translational research (CTR) proposals alone. Other covariates included proposal classification, type of grant award, academic unit, and year.ResultsMICHR had a positive and statistically significant relationship with success for both proposal types. For all grants, MICHR was associated with a 29.6% increase in award size. For CTR grants, MICHR had a statistically nonsignificant relationship with award size.ConclusionsMICHR’s infrastructure, created to enable and enhance CTR, has also created positive spillovers for a broader spectrum of research and grant seeking.

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Sanders, D. C. "1037 DESIGNING THE NEW LAND GRANT UNIVERSITY." HortScience 29, no. 5 (1994): 577a—577. http://dx.doi.org/10.21273/hortsci.29.5.577a.

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Land Grant Universities have undergone tremendous change during the late 1980's and early 1990's. These changes are due to declining resources, changing social needs, the decreasing agricultural components of society, and globalization. Faculty and support positions have been reduced. Research programs have embraced more complex areas of study, leaving adoption of new technologies to extension faculty. The Agricultural Industry has declined in political power as fewer farmers feed more people. All of these conditions lead to many changes in `THE LAND GRANT UNIVERSITY'. These changes have been the subject of extensive and intensive, previous and continuing study, because of Land Grants' dramatic influence on both American and global society. Representatives of various institutions within and on the periphery of these institutions will provide their vision for the future of this great American institution. The objectives of this workshop are as follows: Articulate and illuminate the major changes that face The Land Grant Universities and provide a glimpse of these institutions in the future. How these institutions will and should deal with and respond to these challenges will be discussed in order to provide a picture of the future that will affect all of our membership at the very core. The impact of these changes on various aspects of these universities will be presented as follows: Research and science, by Representative of National Academy of Sciences; Outreach/extension and regional cooperation, Representative of The New England Consortium; Private foundations, Representative of Kellogg Foundation; The greater university view, Chancellor Emeritus UCD. The observations of these speakers should generate important discussions that will affect our society, its members, and American society, as we come face to face with major changes in the paradigm of the Land Grant University.

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Martin, Michael V. "The Land-Grant University in the 21st Century." Journal of Agricultural and Applied Economics 33, no. 2 (2001): 377–80. http://dx.doi.org/10.1017/s1074070800005836.

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There are many in political and higher education circles who have come to believe that land-grant universities have lost their relevance. It is said too frequently that the land-grant tradition no longer fits 21st century realities. The purpose of this paper is to argue energetically that land-grant universities, the land grant model, and the land-grant tradition have never been more relevant nor more important.

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Marchand, Wouter. "Students from all Layers of Society. Study Grants, Parents and the Education of their Children, 1815-2015." Historical Life Course Studies 3 (May 12, 2016): 66–84. http://dx.doi.org/10.51964/hlcs9354.

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This paper investigates how the system of government grants affected individual life chances for students in the Netherlands from 1815 to today, focusing on the accessibility of academic education and opportunities for social mobility. Study grants for adolescents from lower class or low-income families can promote upward intergenerational social mobility, since they remove the financial barriers of continuing education and can lead to occupations of a higher standing. By investigating the social background and careers of a sample of grant students compared to the overall student populations, this paper uncovers to what extent study grants had an effect on an individual and societal scale. During the two centuries under study the aims and size of the grant system changed, causing concerns about the effectiveness of the grants. In the entire nineteenth century grants for university students were restricted to those already enrolled, minimizing the appeal for newcomers from low-income families. The limited number of grants available prevented the system from influencing the composition of the student population fundamentally. However, this changed when the grant system was extended in 1919, and again after 1945 when grant allocation was connected to parental income level. The rapid increase of educational participation and connected democratisation from the 1960s made the grant system influential, however costly. The grant system has been a subject of ongoing political debate during the last few decades, since the grants’ effect on upward social mobility has been called into question.

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Witte, Willard T., Scott Schlarbaum, Roger Sauve, and Phillip C. Flanagan. "PLANT EVALUATION AND INTRODUCTION AT THE TSU-McMINNVILLE NURSERY RESEARCH STATION." HortScience 27, no. 11 (1992): 1175b—1175. http://dx.doi.org/10.21273/hortsci.27.11.1175b.

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Since 1988, efforts have been underway to establish a nursery research station in McMinnville, Warren County, Tennessee. Approximately 80 acres of farm property adjacent to the Collins scenic river has been conveyed to Tennessee State University (TSU) for this purpose. Scientists at TSU, Tennessee Technological University, University of Tennessee, and USDA's National Arboretum and Shade Tree Laboratory have cooperated in obtaining grant funds via the Capacity Building Grants Program to initiate a plant evaluation and introduction program. Replicated trials of woody genera include Acer, Castanea, Cornus, Lagerstroemia, Quercus, Syringa, Ulmus. Herbaceous genera are Echinacea, Hemerocallis, Hosta. Plantings will be made over a three year period as infrastructure at the new station develops. Additional grant proposals have been recently submitted.

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Bell, Stephen. "Using Matching Grants to Facilitate Corporate-University Research Linkages: A Preliminary Examination of Outcomes from One Initiative." Canadian Journal of Higher Education 20, no. 1 (1990): 57–73. http://dx.doi.org/10.47678/cjhe.v20i1.183667.

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In the 1980’s the issue of corporate-university linkages has received markedly increased attention from governments, corporations, and universities. From government’s perspective, the drive to enhance corporate-university linkages is derived from the belief that these linkages will contribute to economic competitiveness. One method that has been used by government to encourage this interaction is through the provision of matching grants. Using public finance theory as the conceptual basis, the paper examines the preliminary outcomes of one government’s matching grant initiative. Through a compilation of data on university research revenues on corporate contract research and a questionnaire to companies that placed the research contracts in universities, the paper shows that matching grants, in the manner provided by the BILD program, may not be an effective mechanism to promote corporate-university research linkages. The paper concludes with some suggestions for further research and discusses the conceptual and methodological hurdles that can be encountered when attempting to asses the outcomes of a matching grant program, particularly as applied to corporate-university linkages.

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Namachchivaya, Beth Sandore, and Jamie McGowan. "Assessing the Library's Grants Program." Evidence Based Library and Information Practice 10, no. 2 (2015): 63. http://dx.doi.org/10.18438/b81w2s.

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Abstract  Objective – The authors analyzed seven years of sponsored research projects at the University of Illinois Library at Urbana–Champaign with the aim of understanding the research trends and themes over that period. The analysis was aimed at identifying areas of future research potential and corresponding support opportunities. Goals included developing institutional research themes that intersect with funding priorities, demystifying grant writing and project management through professional development programs, increasing communication about grant successes; and bringing new faculty and academic staff into these processes. The review and analysis has proven valuable for the Library’s institutional practices, and this assessment may also inform other institutions’ initiatives with grant-writing.  Methods – The authors performed a combination of quantitative and qualitative analyses of the University Library’s grant activities that enabled us to accomplish several goals: 1) establish a baseline of data on funded grants; 2) identify motivations for pursuing grants and the obstacles that library professionals face in the process; 3) establish a stronger support structure based on feedback gathered, and through collaborations with other groups that support the research process; and 4) identify strategic research themes that leverage local strengths and address institutional priorities.  Conclusions – Analysis of Library data on externally funded grants from the University’s Proposal Data System provided insight into the trends, themes, and outliers. Informal interviews were carried out with investigators to identify areas where the Library could more effectively support those who were pursuing and administering grants in support of research. The assessment revealed the need for the Library to support grant efforts as an integral component of the research process

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Abdullah, Louay Qais, and Duraid Faris Khayoun. "Thathir Quality Scholarship Program For Students At University level." Iraqi Administrative Sciences Journal 2, no. 3 (2018): 206–19. http://dx.doi.org/10.33013/iqasj.v2n3y2018.pp206-219.

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The study focused basically on measuring the relationship between the material cost of the students benefits program and the benefits which are earned by it, which was distributed on college students in the initial stages (matinee) and to show the extent of the benefits accruing from the grant program compared to the material burdens which matched and the extent of success or failure of the experience and its effect from o scientific and side on the Iraqi student through these tough economic circumstances experienced by the country in general, and also trying to find ways of proposed increase or expansion of distribution in the future in the event of proven economic feasibility from the program. An data has been taking from the data fro the Department of Financial Affairs and the Department of Studies and Planning at the University of Diyala with taking an data representing an actual and minimized pattern and questionnaires to a sample of students from the Department of Life Sciences in the Faculty of Education of the University of Diyala on the level of success and failure of students in the first year of the grant and the year before for the purpose of distribution comparison. The importance of the study to measure the extent of interest earned in comparision whit the material which is expenseon the program of grant (grant of students) to assist the competent authorities to continue or not in the program of student grants for the coming years.

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Morozumi, Kalene, Tanha Patel, Tim Carey, et al. "4300 Evaluation and structure of the pilot funding program at the University of North Carolina CTSA Hub (NC TraCS)." Journal of Clinical and Translational Science 4, s1 (2020): 72. http://dx.doi.org/10.1017/cts.2020.235.

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OBJECTIVES/GOALS: The goals of this evaluation were 1) to describe the pilot grant application cycle and processes at NC TraCS, 2) to illustrate the impact of pilot grants on extramural grant funding, and 3) to provide a framework for other institutions to utilize for the evaluation of pilot grant programs. METHODS/STUDY POPULATION: From 2009-2019 the NC TraCS pilot program funded 925 projects, varying from $2,000 to $100,000. Pilot grants are available to any researcher affiliated with the university as well as partner institutions and community stakeholders. For this evaluation we analyzed data on pilot applicants (demographics, type of pilot, funding status, resubmissions, etc.) and outcomes (extramural funding, publications, etc.) yielded from funded pilots. In addition to summary statistics, we also calculated return on investment (ROI) for the program as a whole and by specific grant type. We will use bibliometric network analysis to assess productivity, citation impact, and scope of collaboration. RESULTS/ANTICIPATED RESULTS: There have been 2,777 submitted proposals with an acceptance rate of 33.3%. Unfunded proposals can resubmit, 61.8% of resubmitted applications are successfully funded, and 29.6% of funded applications are resubmissions. The $2,000 awards accounted for 43.4% of all grants awarded but only accounted for 6.4% of all pilot funds awarded. Success of proposals was proportional to the number of applications from each academic unit. 60.8% of funded applicants were affiliated with the School of Medicine and account for 65.3% of all funding awarded from 2009-2019. Additionally, we plan on analyzing return on investment rates to illustrate the impact of pilot awards on future research funding. DISCUSSION/SIGNIFICANCE OF IMPACT: Pilot grants can lead to subsequent extramural grants, publications, and successful translation of research into practice. This evaluation will assist our institution in understanding the impact of pilot grants and will provide a road map for other institutions evaluating their own programs.

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Reinschmiedt, Lynn L. "The Information Age University?" Journal of Agricultural and Applied Economics 28, no. 1 (1996): 1–11. http://dx.doi.org/10.1017/s1074070800009391.

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As a preface to my comments today, I challenge you to consider the following questions. Do the information age technological changes now taking place have the potential to disrupt, or even destroy, the university as we know it? Do these changes have the potential to force restructuring of the land-grant system? My comments today will address these questions. In doing so, however, I will not address problems facing the land-grant system or the agricultural economics profession per se, other than those we face as a part of the overall system of higher education. Others are doing that or have addressed those more unique problems elsewhere. A major National Research Council (NRC) initiative is now examining the relevancy of the land-grant system in the context of today's society; the W. K. Kellogg Foundation has funded an initiative to facilitate positive change within the land-grant system (Warner); and Eidman, in his 1995 American Agricultural Economics Association presidential address, summarized key concerns and issues facing the agricultural economics profession and how we are responding to them. I contend that overlaying the NRC and Eidman concerns is a series of fundamental changes taking place that has the potential to drastically modify the higher education model as we presently know and understand it.

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Gass, Susan, Paula Winke, and Koen Van Gorp. "The Language Flagship Proficiency Initiative." Language Teaching 49, no. 4 (2016): 592–95. http://dx.doi.org/10.1017/s0261444816000215.

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The Center for Language Teaching Advancement (CeLTA) at Michigan State University (MSU) was awarded a U.S. federally funded two-year grant in 2014 to investigate the status of proficiency, and the promotion of proficiency, in foreign language programs. The grant was awarded to Paula Winke and Susan Gass, as principal investigators. The purpose of this initiative was to assess language proficiency development and to show the impact that introducing assessment practices into established language programs has on pedagogical practices and, ultimately, on proficiency outcomes. In total, three grants were awarded, one to MSU, one to the University of Utah, and one to the University of Minnesota. The overall goals were the same, although each institution approached the task in slightly different ways and with slightly different emphases.

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Wong, Jehn-yih, Tung-hsuan Wan, and Hung-chih Chen. "The innovative grant of university–industry–research cooperation." International Journal of Innovation Science 10, no. 3 (2018): 316–32. http://dx.doi.org/10.1108/ijis-01-2017-0004.

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PurposeThis study aims to make government usage of technology research grants more efficient and to evaluate how to use university–industry–research cooperation to promote industrial innovation in Taiwan.Design/methodology/approachThis case study aims to use the triple helix model and other references to develop indicators which can estimate the performance of university–industry–research cooperation in Taiwan. The study selects three facets: “(prior) mechanisms,” “(in-progress) regulations” and “(post-hoc) operations” to find out the critical indicators contributing the final outcome. The study found that a successful university–industry–research cooperation requires the following factors: strengthening review methods for the mechanisms; its relationships of rights and obligations; policy needs in regulations; and plan incentives in operations.FindingsIt is recommended that, to promote university–industry–research cooperation in Taiwan, resource distributors and program management units should not only continue program application incentives and strengthen interdepartmental resource integration, they should also consider the establishment of a fair, just and open review mechanisms, and they should enhance the relationship between the rights and obligations of university–industry–research cooperation.Originality/valueThe study of this program includes application review before, during and after the program, management examination and performance evaluation to formulate recommendations as reference points for resource distributors and grant recipients. And because of industry–university cooperation being the main way of research and technology development, the findings and suggestions of this study may also be helpful for other grant systems in the world.

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Marx, Benjamin M., and Lesley J. Turner. "Borrowing Trouble? Human Capital Investment with Opt-In Costs and Implications for the Effectiveness of Grant Aid." American Economic Journal: Applied Economics 10, no. 2 (2018): 163–201. http://dx.doi.org/10.1257/app.20160127.

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We estimate the effect of grant aid on City University of New York (CUNY) students' borrowing and attainment using a regression discontinuity/kink design based on the federal Pell Grant formula. Each dollar of grant aid reduces loans by $1.80 among borrowers. We only find crowd-out of this magnitude in colleges that, like CUNY, “offer” no loan aid and require students to opt into borrowing. We develop and empirically support a model that shows opt-in or other fixed borrowing costs can lead grants to crowd out large amounts of loan aid, lowering some students' attainment by reducing their liquid resources. (JEL D14, I22, I23, I26, J24)

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Galloway, Ann-Christe. "Grants and Acquisitions." College & Research Libraries News 81, no. 4 (2020): 209. http://dx.doi.org/10.5860/crln.81.4.209.

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The Hill Museum & Manuscript Library (HMML) at Saint John’s University has received $1,408,474 in grants from the National Endowment for the Humanities to support its mission to preserve and share the world’s handwritten heritage. The grant will fund a three-year project to catalog 53,000 digitized manuscripts and create an online database of authors and titles originating from under-represented or little-known literary traditions. Of the total amount, $1,208,474 is an outright grant, and $200,000 must be matched by funds raised by HMML.

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Bolding, Timothy. "Opportunities for Anthropologists in a Climate of Change." Practicing Anthropology 13, no. 3 (1991): 11–12. http://dx.doi.org/10.17730/praa.13.3.u67m1v544p722218.

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When I decided to major in anthropology in graduate school my mother cried. I know she thought I would never get a job. But by the time I earned my M.A. from Memphis State University in 1980, I had a full-time job in the legislative and grants writing office of Shelby County, the county in which Memphis is located. The office was called the Internal Coordination Office (ICO), and my primary responsibilities were to identify grant opportunities and work with other departments to prepare grant applications.

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Avery, Robin K., Robin K. Avery, Darin B. Ostrander, et al. "944. CMV Peak Viral Load, Recurrence, Duration, and Outcomes in Kidney Transplant Recipients." Open Forum Infectious Diseases 8, Supplement_1 (2021): S564—S565. http://dx.doi.org/10.1093/ofid/ofab466.1139.

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Abstract Background Cytomegalovirus (CMV) infection continues to cause morbidity in kidney transplant recipients, despite prophylaxis and pre-emptive therapy. Predictors of poor outcomes remain incompletely characterized. We questioned whether markers of CMV replication (CMV peak viral load, recurrent episodes, or duration of CMV DNAemia) are associated with adverse outcomes in the current era. Methods We studied 605 people who underwent kidney transplant at Johns Hopkins University (2010 – 2018). Mean follow-up was 45.5 months. The average age was 51.85 years and 39.7% were female. Donor-seropositive, recipient seronegative (D+/R-) patients received valganciclovir 900 mg/day for 6 months, while R+ patients received valganciclovir 450 mg/day for 3 months. CMV recurrence was defined as CMV DNAemia after two undetectable CMV PCR’s. Outcomes of acute rejection, graft failure, and death were evaluated in univariate analysis; p values were calculated by Fisher’s exact test. Results Peak CMV viral load was not associated with any outcomes (Table 1). There was a trend of increased graft failure in people who had long duration ( &gt;6 month) DNAemia (Table 2). More than two episodes of CMV reactivation was associated with graft failure and rejection (Table 3). Conclusion CMV reactivation is associated with kidney rejection and failure in univariate models. Multivariate analyses and longitudinal modeling will provide increased data upon which to better instruct preventative strategies. Acknowledgments Funding for the research study was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA Disclosures Robin K. Avery, MD, Aicuris (Grant/Research Support)Astellas (Grant/Research Support)Chimerix (Research Grant or Support)Merck (Grant/Research Support)Oxford Immunotec (Grant/Research Support)Qiagen (Grant/Research Support)Takeda/Shire (Grant/Research Support) Yuexin Tang, PhD, JnJ (Other Financial or Material Support, Spouse’s employment)Merck & Co., Inc. (Employee, Shareholder) Kieren Marr, MD, Merck (Grant/Research Support, Advisor or Review Panel member)

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Meyer, James H. "1041 DESIGNING THE NEW LAND GRANT UNIVERSITY." HortScience 29, no. 5 (1994): 577e—577. http://dx.doi.org/10.21273/hortsci.29.5.577e.

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Massive changes occurring in the agricultural industries and expanding societal interests in environmental quality, food safety, competition for natural resources, along with population pressure, are making it `evident Land Grant colleges of agriculture (LGCAs) must reorganize to address a broader interface of both agriculture-related issues and issues relevant to society in general. A reduced focus on agriculture as such must be anticipated, with more emphasis directed toward life sciences, food quality, environmental concerns, and rural-urban interfaces. Since their establishment in 1862, LGCAs have helped U.S. farmers improve production so much that the numbers of people needed in agricultural sector have plummeted, leaving the status and future of these colleges uneasy. Although the original LGCA model was appropriate for its time, the modern environment at scientific and agricultural universities calls for a new model. To achieve renewal, one must change mindset, revise the mission, provide creative, learning leaders and chart the course for evolution of revitalized institutions.

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Pastine, Maureen, Ivy Bayard, and Carol Lang. "Digital Diamond: Temple University Libraries’ IMLS grant." Bottom Line 14, no. 2 (2001): 76–84. http://dx.doi.org/10.1108/08880450110392812.

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Absolon, Kathleen, and Susan Dion. "Doing Indigenous Community-University Research Partnerships: A Cautionary Tale." Engaged Scholar Journal: Community-Engaged Research, Teaching, and Learning 3, no. 2 (2018): 81–98. http://dx.doi.org/10.15402/esj.v3i2.334.

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With the intention of generating critical discussion, in this paper the authors examine the complexities of doing decolonizing research within colonial institutions. Drawing on their experiences as co-investigators on a large scale partnership grant involving Indigenous and non-Indigenous partners doing community-based research in Indigenous communities, they tell a cautionary tale about confronting and working through the challenges. Specifically addressing communication, decision-making, internalized colonialism and research relationships, the authors conclude that while these kinds of partnership grants involve struggle, in the end the effort is necessary.

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Shortridge, Dee, Jennifer M. Streit, Leonard R. Duncan, Mariana Castanheira, and Mariana Castanheira. "1308. Activity of Cefiderocol and Comparators against Gram-negative Isolates from US Patients Hospitalized with Pneumonia." Open Forum Infectious Diseases 8, Supplement_1 (2021): S742—S743. http://dx.doi.org/10.1093/ofid/ofab466.1500.

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Abstract Background Cefiderocol (CFDC) is a novel siderophore-conjugated cephalosporin with broad activity against Gram-negative (GN) bacteria, including carbapenem-resistant isolates, and non-fermentative organisms. CFDC is approved by the FDA for complicated urinary tract infection (cUTI), hospital-acquired bacterial pneumonia, and ventilator-associated bacterial pneumonia. In this study, we analyzed the susceptibility of CFDC and comparators against aerobic nonfastidious GN isolates collected from US patients hospitalized with pneumonia (PHP) in 2020 as a part of the SENTRY Antimicrobial Surveillance Program. Methods A total of 1,877 Gram-negative isolates were consecutively collected from PHP in 27 US hospitals during 2020. Susceptibility (S) testing was performed using the CLSI broth microdilution method. CFDC was tested in iron-depleted Mueller-Hinton broth. CLSI or FDA (2021) breakpoints were used. Both CLSI and FDA (2021) interpretations are shown in the table. Carbapenem-resistant Enterobacterales (CRE, nonsusceptible to imipenem and/or meropenem) and extensively drug resistant (XDR, susceptible to ≤ 2 drug classes) phenotype isolates were analyzed. Results The most common GN organism isolated from PHP was Pseudomonas aeruginosa (PSA, n=570), followed by Klebsiella pneumoniae (n=239). The %S and MIC50/90 values of CFDC for both CLSI and FDA breakpoints and comparators are shown in the table for all organisms and resistant subsets. For Enterobacterales, all tested drugs had &gt;99%S. The 18 CRE isolates had 94.4%S to CFDC and ceftazidime-avibactam. CFDC was the most active antimicrobial tested against PSA (99.3/98.4%S, CLSI/FDA) and XDR PSA (94.6/93.2%). CFDC had the highest %S against Acinetobacter baumannii-calcoaceticus species complex (ABC, 97.0/93.1%S, CLSI/FDA), XDR ABC (94.6/93.2%), and against Stenotrophomonas maltophilia (SM; 100.0/97.1%S, CLSI 2020/2022). Conclusion CFDC was highly active against US GN isolates from PHP, including CRE, XDR PSA and ABC, as well as SM. These in vitro results suggest that CFDC may be an important option for the treatment of PHP caused by GN organisms, particularly for pathogens which have few treatment options. Disclosures Dee Shortridge, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support) Jennifer M. Streit, BS, GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Leonard R. Duncan, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Shionogi (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Shortridge, Dee, S. J. Ryan Arends, Jennifer M. Streit, Mariana Castanheira, and Mariana Castanheira. "1280. Minocycline Activity Against Acinetobacter baumannii-calcoaceticus Species Complex, Burkholderia Cepacia Complex, and Stenotrophomonas maltophilia from US Hospitals." Open Forum Infectious Diseases 8, Supplement_1 (2021): S728. http://dx.doi.org/10.1093/ofid/ofab466.1472.

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Abstract Background Acinetobacter baumannii-calcoaceticus species complex (ACB), Burkholderia cepacia complex (BCC), and Stenotrophomonas maltophilia (SM) are opportunistic non-fermentative organisms that can cause serious hospital-acquired infections in immunocompromised patients. These pathogens are inherently resistant to several common drug classes and often acquire other resistance mechanisms, making them difficult to treat. In this study, we analyzed the susceptibility of contemporary ACB, BCC, and SM isolates to minocycline (MIN), ceftazidime (TAZ), levofloxacin (LEV), and trimethoprim-sulfamethoxazole (T/S). Isolates were collected as a part of the SENTRY Antimicrobial Surveillance Program from 2017-2020. Methods Isolates were collected from hospitalized patients in 33 US medical centers. Hospitals submitted 1 isolate per patient per infection episode that met local criteria for being the likely causative pathogen. Identification was performed by the submitting laboratory and confirmed by JMI Laboratories with matrix-assisted laser desorption ionization-time of flight mass spectrometry or other standard methods as required. Isolates were tested for susceptibility (S) to MIN and comparators using the CLSI broth microdilution method. All infection types were included in the analysis. CLSI (2021) breakpoints were applied. Results The most common infection that ACB, BCC, and SM were isolated from was pneumonia in hospitalized patients (57.9%, 81.1%, and 73.9%, respectively) followed by skin and skin structure infections for ACB (21.5%) or bloodstream infections for BCC (13.5%) and SM (11.8%). The %S and MIC50/90 values of the 4 drugs tested against the organisms in this study are shown in the table. MIN had the highest %S for ACB (85.9%S) and SM (99.3%S). TAZ had the highest %S (87.8%S) for BCC, while MIN and T/S had similar %S at 82.4%S and 83.8%S, respectively. Conclusion MIN had &gt;82% S for the pathogens in this study, which have limited therapeutic alternatives. Options are particularly limited for BCC and SM, which have only 7 drugs with CLSI breakpoints. These in vitro data suggest that MIN remains a useful treatment option for infections caused by ACB, BCC, or SM. Disclosures Dee Shortridge, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support) S J Ryan Arends, PhD, AbbVie (formerly Allergan) (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Jennifer M. Streit, BS, GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Shortridge, Dee, Jennifer M. Streit, Michael D. Huband, Mariana Castanheira, and Mariana Castanheira. "155. In Vitro Evaluation of Delafloxacin Activity Against Contemporary US Isolates from Community-Acquired Pneumonia and Community-Acquired Lower Respiratory Tract Infections: Results from the SENTRY Antimicrobial Surveillance Program (2014-2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S93—S94. http://dx.doi.org/10.1093/ofid/ofab466.155.

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Abstract Background Delafloxacin (DLX) is a broad-spectrum fluoroquinolone antibacterial approved in the US for the treatment of community-acquired bacterial pneumonia (CABP). DLX is indicated to treat CABP caused by Streptococcus pneumoniae (SPN), Haemophilus influenzae (HI), Haemophilus parainfluenzae (HP), methicillin-susceptible Staphylococcus aureus (MSSA), Escherichia coli (EC), Klebsiella pneumoniae (KPN), Pseudomonas aeruginosa (PSA), Chlamydia pneumoniae, Mycoplasma pneumoniae and L. pneumophila. In this study, the in vitro susceptibilities of DLX and comparator quinolones were determined for clinical isolates from CAP and CA-lower respiratory tract infections (LRTIs). Methods CAP and CA-LRTI isolates were consecutively collected at 67 US medical centers participating in the SENTRY Surveillance Program during 2014-2020. Sites submitted 1 isolate per patient per infection episode. Isolate identification was determined at each site and confirmed using standard biochemical or molecular methods at JMI Laboratories. Susceptibility testing was performed according to CLSI broth microdilution methodology. CLSI (2021) interpretive criteria were applied, FDA criteria were used for DLX. Results The susceptibility results for DLX, levofloxacin (LEV), moxifloxacin (MOX), and ciprofloxacin (CIP) for the indicated species are shown in the table. As MOX does not have CLSI breakpoints for EC, KPN, or PSA, CIP was tested for those species instead. DLX had the highest percent susceptibility against MSSA (91.8%). SPN and HI were &gt;97% susceptible, and HP was &gt;91% for all 3 drugs. KPN susceptibility ranged from 86.4% for LEV to 76.9% for DLX. Susceptibilities for EC and PSA were similar for the 3 drugs, EC varied from 59.8% for LEV to 57.0% for DLX, and PSA varied from 71.6% for CIP to 64.0% to LEV. Conclusion DLX had good activity against recent CAP and CA-LRTI isolates from US hospitals. DLX had the highest susceptibility of the quinolones tested against MSSA. Quinolone-resistant SPN and HI were uncommon. These in vitro results suggest that DLX may be a useful therapeutic option for CABP caused by Gram-positive, Gram-negative and fastidious pathogens. Disclosures Dee Shortridge, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support) Jennifer M. Streit, BS, GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Michael D. Huband, BS, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Lindley, Jill, Yahse Edah, Olga Lomovskaya, Mariana Castanheira та Mariana Castanheira. "1053. The β-Lactamase Inhibitor QPX7728 Restores the Activity of β-Lactam Agents against Contemporary Extended-Spectrum β-lactamase (ESBL)-Producing and Carbapenem-Resistant Enterobacterales (CRE) Isolates, Including Isolates Producing Metallo-β-lactamases". Open Forum Infectious Diseases 8, Supplement_1 (2021): S617—S618. http://dx.doi.org/10.1093/ofid/ofab466.1247.

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Abstract Background The β-lactam (BL)/ β-lactamase inhibitor (BLI) combinations approved in the last 10 years are active against most ESBL-producing Enterobacterales (ENT) and CRE isolates, but have limited activity against metallo-β-lactamase (MBL)-producing ENT. We evaluated the activity of QPX7728 (QPX), a novel BLI with intravenous (IV) and oral availability, in combination with BL agents. We tested ENT isolates carrying the most common BL genes such as blaCTX-M, transferable AmpCs, oxacillinases, MBLs, and serine carbapenemases. Methods A total of 1,027 ENT isolates were susceptibility (S) tested by reference broth microdilution against aztreonam (ATM), cefepime (FEP), cefdinir (CDR), ceftibuten (CTB), ceftolozane (CT) and piperacillin (PT) with fixed 4 mg/L of tazobactam, biapenem (BPM), meropenem (MER), and tebipenem (TEB) combined with QPX at fixed 4 and 8 mg/L. All isolates were genetically characterized using whole genome sequencing and included 520 ESBL-producers and 507 CRE with 168 producing MBLs. Results BL agents tested alone had limited activity against this challenge set of isolates (MIC90, ≥32 mg/L); however, MIC90 values decreased ≥32-fold with the addition of QPX at the highest concentration tested (Table). Oral agents, CTB,CDR and TEB were tested with QPX at a fixed 4 mg/L and showed a 32- to 128-fold increase in potency (MIC90, 0.5-4 mg/L). ATM and FEP were tested with QPX at a fixed 4 and 8 mg/L and displayed MIC90 values ranging from 0.12-0.5 mg/L. ATM and FEP, tested with 8 mg/L of QPX, inhibited 99.8% of isolates at the breakpoint for the BL agent alone. BLI inhibitor combinations PT and CT displayed MIC90 values of 2 and 4 mg/L with the addition of 8 mg/L QPX. MER with QPX at a fixed 4 mg/L and 8 mg/L inhibited 99.8% and 100% of isolates, respectively. Conclusion The activity of all BLs evaluated was restored when combined with QPX tested against this challenging collection of 1,027 ENT isolates displaying various resistance mechanisms, including difficult to treat CRE isolates and MBL producers. Further development of QPX with various orally- and IV-available BL agents appears warranted. Disclosures Jill Lindley, Bravos Biosciences (Research Grant or Support)ContraFect Corporation (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support) Yahse Edah, AS, Qpex (Research Grant or Support) Olga Lomovskaya, PhD, Qpex Biopharma (Employee) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Aslan, Abashidze H., Gugunskiy A. Denis, Kiseleva E. Ekaterina, Koneva V. Aleksandra, and Solntsev M. Aleksandr. "XVI BLISCHENKO CONGRESS OVERVIEW Moscow, RUDN University, April 14, 2018." RUDN Journal of Law 22, no. 4 (2018): 587–601. http://dx.doi.org/10.22363/2313-2337-2018-22-4-587-601.

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On April 14, 2018, the Department of International Law, Law Institute, RUDN University held the annual XVI Annual Blischenko Congress. The main work of the Blischenko Congress traditionally took place in sections focused on the main branches of international law. Co-organizers of the International Congress were international organizations, representative offices and departments. This research event was organized with grant support from: Russian Foundation for Basic Research; the grant of the President of the Russian Federation for the state support of young researches; grant of the Russian Science Foundation.

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Castanheira, Mariana, Mariana Castanheira, Lalitagauri M. Deshpande, Timothy B. Doyle, Rodrigo E. Mendes та Helio S. Sader. "1284. Occurrence of β-Lactamases among Enterobacterales Isolated from United States Hospitals: Results of the INFORM Surveillance Program for Ceftazidime-Avibactam". Open Forum Infectious Diseases 8, Supplement_1 (2021): S730—S731. http://dx.doi.org/10.1093/ofid/ofab466.1476.

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Abstract Background Carbapenems are broadly used for the treatment of ESBL-producing Enterobacterales isolates. The use of these agents led to an increase of carbapenem resistance among Enterobacterales. Monitoring isolates that carry β-lactamases is important to understand their prevalence and susceptibility to clinically available antimicrobial agents. We evaluated the prevalence of β-lactamases and the activity of antimicrobial agents against 1,209 isolates collected in 69 US hospitals. Methods A total of 9,686 Enterobacterales isolates collected during 2019 were susceptibility (S) tested by reference broth microdilution methods. Isolates submitted to whole genome sequencing were: (1) Escherichia coli (EC) and Klebsiella pneumoniae (KPN; n=817) displaying MIC values ≥2 mg/L for at least 2 of the following β-lactams: ceftazidime, ceftriaxone, aztreonam, or cefepime; (2) Enterobacter cloacae (ECL) and Citrobacter spp. (CIT; n=351) displaying MIC values ≥16 mg/L for ceftazidime and/or ≥2 mg/L for cefepime; and (3) Enterobacterales (n=118) displaying elevated carbapenem (meropenem and/or imipenem) MIC results at &gt;1 mg/L. Results A total of 723 isolates harbored ESBL genes but did not carry carbapenemases. The most common ESBL gene was blaCTX-M-15 (n=516), followed by blaCTX-M-14 (n=153). Most of these isolates were EC (278/147 for blaCTX-M-15/blaCTX-M-14), but 220 KPN harbored blaCTX-M-15. A total of 302 EC and KPN isolates carried blaOXA-1. Among ECL and CIT, blaCTX-M-15 and SHV genes encoding ESBLs were noted among 18 and 18 isolates. Carbapenemase genes were noted among 77 isolates, including 65 blaKPC, 3 blaSME, 6 blaOXA-48-like, and 3 blaNDM. Ceftazidime-avibactam (CAZ-AVI) was the only agent active against all ESBL-producers that did not carry carbapenemases (Table). CAZ-AVI was active against 90.9% of the isolates producing carbapenemases. Isolates resistant to this combination included 3 NDM-producers and 1 isolate harboring blaKPC-31. Conclusion Enterobacterales isolates carrying ESBLs, mainly blaCTX-M-15, were very prevalent in this collection of US isolates. CAZ-AVI was very active against isolates tested, including isolates producing carbapenemases that displayed resistance to many comparator agents. Disclosures Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Lalitagauri M. Deshpande, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Pfizer, Inc. (Research Grant or Support) Timothy B. Doyle, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support)

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Carvalhaes, Cecilia G., Jaideep Gogtay, Cheung Yee, et al. "1229. Antimicrobial Activity of Plazomicin against Multidrug-resistant Enterobacterales: Results from 3 Years of Surveillance in Hospitals in the United States (2018–2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S703—S704. http://dx.doi.org/10.1093/ofid/ofab466.1421.

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Abstract Background Multidrug-resistant (MDR) Enterobacterales isolates have increased and remain elevated in many US hospitals. Aminoglycoside (AMG) resistance often co-exist with resistance to other classes of antibiotics. A newer aminoglycoside, plazomicin, was evaluated against a large collection of MDR Enterobacterales clinical isolates from US hospitals. Methods A total of 456 MDR isolates (1/patient) were collected from 32 US medical centers located in 23 states in 2018-2020 and susceptibility tested by broth microdilution method at a central laboratory. MDR was defined as nonsusceptible (NS) to ≥3 antimicrobial classes and extensively drug-resistant (XDR) as susceptible (S) to ≤2 classes. Isolates resistant to aminoglycosides and/or broad-spectrum cephalosporins were screened for aminoglycoside-modifying enzymes (AME), 16S rRNA methyltransferases, and β-lactamases by whole genome sequencing. Results PLZ inhibited 93.0% of the MDR isolates (MIC50/90, 0.5/1 mg/L) and showed MIC values 8- to 16-fold lower than amikacin (AMK; MIC50/90, 4/16 mg/L; 93.2%S; Table). AMK S rates were 84.6% and 69.3% when EUCAST (≤8 mg/L) and USCAST (≤4 mg/L) breakpoints were applied, respectively. Among agents from other classes, S rates were 85.5% for meropenem, 88.4% for tigecycline, 49.3% for piperacillin-tazobactam, and 17.8% for cefepime; only the carbapenems and tigecycline were active against &gt;50% of MDR isolates. PLZ retained activity against isolates NS to AMK (83.9%S), gentamicin (GEN; 89.3%S), and/or tobramycin (TOB; 92.4%S). PLZ showed markedly higher S rates than AMK against XDR (93.3% vs. 71.7%), AME producers (97.6% vs. 90.2%), and carbapenemase (CPE) producers (98.1% vs. 67.9%). PLZ was active against 99.0% of ESBL producers, while AMK S rates were 96.2%/87.0% as per the US FDA/EUCAST against these organisms. PLZ and AMK showed similar S rates when tested against GEN-NS isolates. GEN and TOB exhibited limited activity against MDR and all resistant subsets. Conclusion Despite co-resistance to aminoglycosides and other classes of antibiotics observed with MDR Enterobacterales isolates, PLZ remained highly active against these isolates including AME-, ESBL-, and/or CPE-producers that cause infections in US hospitals. Table Disclosures Cecilia G. Carvalhaes, MD, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support) Jaideep Gogtay, n/a, Cipla Therapeutics (Employee)Cipla USA Inc. (Employee) Cheung Yee, MSc, PhD, Cipla Therapeutics (Employee) Sandhya Das, n/a, Cipla Therapeutics (Employee) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support)

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Sader, Helio S., Mariana Castanheira, Mariana Castanheira, Leonard R. Duncan, and Rodrigo E. Mendes. "1236. Update on the In Vitro Activity of Ceftaroline against Staphylococcus aureus from United States (US) Medical Centers Stratified by Infection Type (2018-2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S707—S708. http://dx.doi.org/10.1093/ofid/ofab466.1428.

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Abstract Background Ceftaroline was initially approved by the US FDA in 2010 to treat skin and skin structure infection (SSSI) and community-acquired bacterial pneumonia (CABP). FDA approval was extended in 2015 to treat patients with SSSI and CABP who developed bacteremia. Moreover, ceftaroline has also been used off-label to treat other infection types. We evaluated the in vitro activity of ceftaroline against S. aureus isolated in US medical centers in 2018-2020. Methods A total of 9,268 S. aureus isolates were consecutively collected from 33 US medical centers in 2018-2020 and susceptibility tested by broth microdilution method against ceftaroline and comparators. Results were stratified by infection type and resistance profile. Results Ceftaroline (MIC50/90, 0.25/1 mg/L) susceptibility (S) ranged from 98.5% (SSSI) to 95.4% (pneumonia; 97.2% overall [Table]). Ceftaroline retained potent activity and broad spectrum against methicillin-resistant S. aureus (MRSA; 41.9% of isolates), with S rates varying from 96.3% (SSSI) to 89.2% (pneumonia; 93.4% overall). Overall S rate to erythromycin (ERY), levofloxacin (LEV), tetracycline (TET), and trimethoprim-sulfamethoxazole (TMP-SMX) were 44.0%, 67.9%, 94.1%, and 97.5%, respectively. Ceftaroline retained good activity against S. aureus resistant to ERY (94.8%S), LEV (91.4%S), TET (92.3%S), and/or TMP-SMX (98.7%S). Among the resistant subsets, ceftaroline S rates were generally highest among isolates from SSSI (93.1-100.0%), followed by other infections (81.8-100.0%), bloodstream infections (BSI; 89.4-96.2%), and pneumonia (86.6-98.1%); overall susceptibility was highest among TMP-SMX-R isolates (98.7%), followed by ERY-R (94.8%), MRSA (93.4%), TET-R (92.3%), and LEV-R (91.4%) isolates. Dalbavancin (MIC90, 0.03 mg/L), teicoplanin (MIC90, 0.5 mg/L), and vancomycin (MIC90, 1 mg/L) exhibited complete activity (100.0%S), whereas daptomycin (MIC90, 0.5 mg/L) and linezolid (MIC90, 2 mg/L) were active against &gt;99.9% of isolates. Conclusion Ceftaroline remained very active against contemporary (2018-2020) S. aureus from US medical centers, independent of infection type. Ceftaroline retained good activity against MRSA and isolates resistant to ERY, LEV, TET, and/or TMP-SMX. Disclosures Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Leonard R. Duncan, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Shionogi (Research Grant or Support) Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support)

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Mendes, Rodrigo E., Ian A. Critchley, Nicole Cotroneo, et al. "1057. Tebipenem In vitro Activity Against a Collection of Pathogens Responsible for Urinary Tract Infections in the US." Open Forum Infectious Diseases 8, Supplement_1 (2021): S620—S621. http://dx.doi.org/10.1093/ofid/ofab466.1251.

Full text

Abstract:

Abstract Background Enterobacterales (ENT)—especially Escherichia coli (EC), Klebsiella pneumoniae (KPN), and Proteus mirabilis (PM)—are widely implicated in urinary tract infections (UTIs). Many oral agents are used to manage UTIs, but their usefulness has been compromised by the increased prevalence of extended-spectrum β-lactamases (ESBL) and presence of co-resistance to trimethoprim-sulfamethoxazole (TMP/SMX) and quinolones. Tebipenem (TBP) is an oral carbapenem in clinical development for treating complicated UTIs and acute pyelonephritis. This study assessed the in vitro activity of TBP and comparator agents against ENT responsible for UTIs in the US during 2019-2020. Methods A total of 3,576 ENT recovered from urine samples during the 2019-2020 STEWARD Surveillance Program were included in the study. Isolates were collected from medical centers in all 9 US Census Regions and were centrally tested for susceptibility by reference broth microdilution method. MIC interpretation was performed based on CLSI criteria. Results EC comprised 65.6% of all ENT pathogens, followed by KPN (14.3%), PM (6.6%), and other species (13.7%). TBP (MIC90, 0.015-0.06 mg/L) and ertapenem (ERT; MIC90, 0.03 mg/L) showed similar MIC90 results against ENT, EC, and KPN (Table). Ceftazidime (CAZ; MIC90, 8-16 mg/L) had elevated MIC90 values and suboptimal susceptibility results (86.1-89.3%) against ENT, EC, and KPN. The oral agents, cefuroxime, amoxicillin-clavulanate, TMP-SMX, and levofloxacin showed susceptibility rates ranging from 63.1% to 87.1% against ENT, EC, and KPN. TBP (MIC50/90, 0.12/0.12 mg/L) inhibited all PM at ≤0.25 mg/L. PM isolates were susceptible to ERT (100.0%), CAZ (98.7%), cefuroxime (94.4%), and amoxicillin/clavulanate (96.6%), whereas susceptibility rates of 71.8-76.8% were noted for TMP-SMX and levofloxacin. Conclusion TBP displayed potent activity against ENT UTI pathogens recovered from patients in the US. TBP demonstrated in vitro activity against these UTI pathogens similar to that of ERT. In addition, these data showed compromised activity of intravenous and oral agents used for treating UTI. This data supports the development of tebipenem as an oral option for management of UTI in the US. Disclosures Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Ian A. Critchley, Ph.D., Spero Therapeutics (Employee, Shareholder) Nicole Cotroneo, Spero Therapeutics (Employee, Shareholder) Jennifer M. Streit, BS, GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Castanheira, Mariana, Mariana Castanheira, Timothy B. Doyle, Valerie Kantro, Rodrigo E. Mendes, and Dee Shortridge. "1218. Activity of Meropenem-Vaborbactam and Comparator Agents Against Carbapenemase-Negative, Carbapenem-Resistant Enterobacterales from US Hospitals." Open Forum Infectious Diseases 8, Supplement_1 (2021): S698—S699. http://dx.doi.org/10.1093/ofid/ofab466.1410.

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Abstract:

Abstract Background Meropenem-vaborbactam (MVB) is an important addition to the armamentarium to treat infections caused by carbapenem-resistant Enterobacterales (CREs). Carbapenemase-negative (CN) CRE isolates have been reported, but the activity of newer agents against these isolates is still not well understood. We evaluated the activity of MVB against CN-CRE collected during 6 years of surveillance in US hospitals. Methods A total of 27,968 Enterobacterales isolates collected in US hospitals from 2014-2019 were susceptibility tested by reference broth microdilution methods. Results were interpreted using CLSI 2020 breakpoints. CRE isolates were submitted to PCR/sequencing (2014-2015) or whole genome sequencing (WGS; 2016-2019) for characterization of carbapenemase genes. Isolates from 2016-2019 were evaluated for other beta-lactam resistance mechanisms. Results Among 357 (1.3% of all isolates) CRE isolates identified during 6 years of surveillance, 48 (13.4% of the CRE) isolates did not produce known carbapenemases. The CN-CRE collection included 7 bacterial, species, or species complex. The top four most common species in the collection were K. pneumoniae (16 isolates) followed by E. cloacae (9), E. coli (8), and K. aerogenes (8). MVB was the most active agent tested against these isolates, inhibiting 47/48 (97.9%) of the isolates tested. The only isolate displaying a resistant MIC for MVB was a P. mirabilis (MIC, 16 mg/L) collected in 2015. Meropenem alone inhibited only 2.1% of the isolates. Other beta-lactams inhibited 4.2 to 14.6% of the isolates. Among non-beta-lactam comparator agents, tigecycline and amikacin inhibited 93.8 and 91.7% of the isolates, respectively, when applying CLSI or US FDA breakpoints. A total of 89.6% of the isolates had intermediate colistin MIC values. Among the 27 isolates collected from 2016-2019 that were submitted to WGS, 15 harbored CTX-M encoding genes. K. aerogenes and E. cloacae isolates (3 each) overexpressed AmpC. OmpC/K36 was disrupted in 20 isolates and OmpF/K35 was disrupted in 8 isolates. Conclusion MVB displayed good activity against CN-CRE isolates from US hospitals. This combination agent could be a good option to treat infections caused by these isolates. Disclosures Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Timothy B. Doyle, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Valerie Kantro, n/a, Melinta Therapeutics, Inc. (Research Grant or Support) Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Dee Shortridge, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)

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Mendes, Rodrigo E., Timothy B. Doyle, Ian A. Critchley, et al. "1254. Molecular Epidemiology of Escherichia coli Causing Urinary Tract Infections in United States and in vitro Activity of Tebipenem, Including Against Strain Lineage and Resistant subsets (2018-2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S715—S716. http://dx.doi.org/10.1093/ofid/ofab466.1446.

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Abstract:

Abstract Background Tebipenem (TBP) is an oral carbapenem in clinical development for treating complicated urinary tract infections (UTIs), including pyelonephritis. This study investigates the epidemiology of E. coli (EC) causing UTI in U.S. patients and the activity of TBP and comparators against various subsets. Methods A total of 2,395 EC recovered from urine samples during the 2018-2020 STEWARD Surveillance Program were included. Isolates were collected from medical centers in all 9 US Census Regions and centrally tested by reference broth microdilution method. MIC interpretation was based on CLSI criteria. Isolates that met MIC criteria were subjected to genome sequencing, followed by screening of extended-spectrum β-lactamase (ESBL) genes and epidemiology typing (MLST). Results A total of 16.1%, 15.4% and 14.6% of EC met the ESBL screening criteria in 2018, 2019 and 2020, respectively. 269/360 (74.7%) carried blaCTX-M and 2/360 (0.6%) had blaSHV-12. blaCMY (33/360; 9.2%) was the most common cephalosporinase, followed by blaDHA (7/360; 1.9%). A CRE phenotype was noted in 1 isolate from New York, which carried blaKPC-2. Acquired genes were not detected in 56 strains. 50 ST types were noted in isolates that met the ESBL criteria screening, with the majority of isolates being ST131 (56.2%). 21 (6.7%) and 19 (6.0%) isolates belonged to ST38 and ST1193, respectively, followed by STs represented by 8 or less isolates. Among ST131, 56.5% carried blaCTX-M from group 1 and 35.6% had genes associated with group 9. Overall, TBP showed consistent MIC50 values throughout the subsets. ERT had activity (≥97.0% susceptible) against the various subsets; however, lower susceptibility rates (85.7-90.6%) were noted against isolates carrying plasmid AmpC. Other agents (ceftriaxone and cefazolin) had activity only against non-ESBL producers. Conclusion bla CTX-M comprised the majority of acquired genes detected among ESBL strains, which belonged mostly to ST131, emphasizing the expansion of this clone. TBP showed consistent activity against all subsets, regardless of resistance genotype or lineage. These data support the clinical development of TBP as a convenient oral treatment option for UTI caused by EC. Disclosures Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Timothy B. Doyle, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Ian A. Critchley, Ph.D., Spero Therapeutics (Employee, Shareholder) Nicole Cotroneo, Spero Therapeutics (Employee, Shareholder) Jennifer M. Streit, BS, GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Sader, Helio S., Jill Lindley, Lalitagauri M. Deshpande, Timothy B. Doyle, Mariana Castanheira, and Mariana Castanheira. "1081. Antimicrobial Activity of Ceftibuten-Avibactam against Clinical Isolates of Enterobacterales Producing Clinically Relevant Beta-Lactamases." Open Forum Infectious Diseases 8, Supplement_1 (2021): S632. http://dx.doi.org/10.1093/ofid/ofab466.1275.

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Abstract:

Abstract Background Ceftibuten (CTB) is an oral cephalosporin active against Enterobacterales approved by the US Food and Drug Administration in 1995. Avibactam (AVI) is a potent inhibitor of extended-spectrum β-lactamases (ESBLs), serine carbapenemases and AmpC that can be administered orally. We evaluated the in vitro activity of CTB-AVI against molecularly characterized Enterobacterales that produced the most common β-lactamases (BLs) and assessed the AVI concentration to be combined with CTB for susceptibility testing. Methods The organism collection (n=71) included Enterobacterales producing ESBLs (28; CTX-M, SHV, and TEM), KPCs (8), MBLs (7; NDM, VIM, and IMP), AmpC derepressed (3), plasmid AmpC (3), OXA-48-like (2), and SME (2) as well as isolates with porin alterations (5) and wild-type organisms (13). Resistance mechanisms were evaluated by whole genome sequencing. MIC values were determined by broth microdilution of CTB with fixed concentrations (2, 4, and 8 mg/L) and ratios (1:1 and 2:1) of AVI. Results The fixed AVI concentration of 4 mg/L best separated CTB-AVI-susceptible from CTB-AVI-resistant isolates. CTB-AVI (fixed 4 mg/L) was very active against Enterobacterales producing ESBL (MIC50/90, 0.03/0.12 mg/L), including CTX-M-15 (MIC50/90, 0.03/0.12 mg/L), KPC (MIC50, 0.06 mg/L), derepressed AmpC (MIC range, 1-2 mg/L), plasmidic AmpC (MIC range, 0.12-0.5 mg/L), SME (MIC range, 0.06-0.12 mg/L), and OXA-48-like (MIC range, 0.5-4 mg/L), but it showed limited activity against MBL-producers (MIC50, &gt;128 mg/L) and isolates with porin alterations (MIC50, 32 mg/L; Table). CTB was very active against SME-producers (MIC, 0.12-0.25 mg/L) and showed some activity against KPC-producers (MIC50, 4 mg/L; MIC range, 2-16 mg/L) and ESBL-producers (MIC50/90, 4/64 mg/L), but it exhibited very limited activity against MBL, AmpC derepressed, plasmidic AmpC, and OXA-48-like producers (MIC50 values of 128 to &gt;128 mg/L). Conclusion CTB-AVI showed potent in vitro activity against Enterobacterales producing most clinically relevant BLs, including ESBLs, KPCs, OXA-48-like, and AmpC, for which limited oral treatment options are available. These in vitro results support further clinical development of CTB-AVI. Disclosures Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Jill Lindley, Bravos Biosciences (Research Grant or Support)ContraFect Corporation (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support) Lalitagauri M. Deshpande, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Pfizer, Inc. (Research Grant or Support) Timothy B. Doyle, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Castanheira, Mariana, Mariana Castanheira, Rodrigo E. Mendes, and Helio S. Sader. "202. Comparative Activity of Ceftazidime-Avibactam, Imipenem-Relebactam and Meropenem-Vaborbactam Tested Against Carbapenem-Nonsusceptible Enterobacterales that Are Carbapenemase-Negative." Open Forum Infectious Diseases 8, Supplement_1 (2021): S123—S124. http://dx.doi.org/10.1093/ofid/ofab466.202.

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Abstract Background Most carbapenem-nonsusceptible Enterobacterales (CNSE) produce carbapenemases, but some isolates do not carry these enzymes. Ceftazidime-avibactam (CAZ-AVI), meropenem-vaborbactam (MBV), and imipenem-relebactam (IMR) have activity against CNSE isolates producing serine-carbapenemases, but these agents might have variable activity against isolates that do not produce these enzymes. We evaluated the activity of these agents against a collection of 170 carbapenemase-negative CNSE collected during 5 years in US hospitals. Methods Enterobacterales isolates (n=47,858) collected in US hospitals from 2016-2020 were susceptibility (S) tested by reference broth microdilution methods. Results were interpreted using CLSI 2020 breakpoints. CNSE displayed nonsusceptible (NS) MICs for imipenem or meropenem. CNSE isolates were screened for carbapenemase genes using whole genome sequencing. Results Among 685 (1.4% of the isolates) CNSE, 170 (24.8% of the CNSE) isolates did not produce carbapenemases. Most of these isolates were K. aerogenes (n=42), K. pneumoniae (32), and E. cloacae (32), but 13 other species also were carbapenemase negative. CAZ-AVI inhibited all carbapenemase-negative CNSE isolates (Figure). MBV and IMR inhibited 97.6% and 92.3% of the isolates. Amikacin (AMK) and tigecycline (TIG) inhibited 97.1% and 93.5%, while levofloxacin and meropenem (MEM) inhibited 63.5% and 64.7%. A total of 141 (82.9%) isolates were nonsusceptible (NS) to imipenem. When MEM NS isolates (n=60) were analysed separately, the S rates were lower for all agents except CAZ-AVI. CAZ-AVI inhibited all MEM NS carbapenemase-negative CNSE isolates. MBV and IMR inhibited 93.1% and 89.7% of these isolates, respectively. AMK and TIG inhibited 93.3% and 88.3%, respectively. Only 8.3% of the isolates were resistant to colistin. Conclusion CAZ-AVI displayed good activity against carbapenemase-negative CNSE isolates, including all MEM NS that displayed greater resistance rates against all comparator agents. High-risk patients with infections caused by CNSE have an increased mortality rate compared to isolates susceptible to these agents. Implementation of appropriate therapy for these isolates is critical. Disclosures Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support)

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Mendes, Rodrigo E., Nicole Cotroneo, Ian A. Critchley та ін. "1036. In Vitro Analysis of AmpC β-lactamase Induction by Tebipenem in Enterobacterales and Pseudomonas aeruginosa". Open Forum Infectious Diseases 8, Supplement_1 (2021): S608—S609. http://dx.doi.org/10.1093/ofid/ofab466.1230.

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Abstract:

Abstract Background Tebipenem (TBP) is an orally bioavailable carbapenem in clinical development in the US for treating complicated urinary tract infections and acute pyelonephritis. TBP possesses broad-spectrum activity against isolates producing penicillinases, narrow- and extended-spectrum β-lactamases, and AmpC β-lactamases. Exposure to β-lactams has been shown to increase AmpC production and impact susceptibility to β-lactams. This study assessed the induction properties of TBP over AmpC production in Gram-negative organisms. Methods Eight Enterobacterales species and 1 P. aeruginosa isolate were selected for AmpC induction experiments for TBP, imipenem, ertapenem (ETP), and ceftazidime. Induction experiments were performed at 0.25, 1, 4, and 16x MIC. AmpC induction was detected by measuring the intensity of nitrocefin hydrolysis compared to baseline. Isolates where a ≥4x induction of AmpC was detected were tested for susceptibility by the CLSI reference broth microdilution method. A second set of 36 Enterobacterales and 32 P. aeruginosa isolates with proven overexpression of AmpC by qRT-PCR were tested for susceptibility as well. Results In general, TBP and imipenem increased production of AmpC against all Enterobacterales, except for C. koseri and S. marcescens (Table). In contrast, ETP and ceftazidime did not seem to affect production of AmpC among the Enterobacterales species tested. All agents but ETP increased the production of AmpC in P. aeruginosa. Overall, an MIC increase (i.e., &gt;4-fold) to various β-lactam agents was not observed when tested against isolates that showed an increased production of AmpC after drug exposure. When tested against the second set of Enterobacterales that over-produced AmpC, TBP (MIC50/90, 0.03/0.25 mg/L) inhibited all isolates at ≤1 mg/L. TBP showed MIC50 and MIC90 results of 4 and 4 mg/L, respectively, against P. aeruginosa isolates that over-produced AmpC. Conclusion Among Enterobacterales, exposure to either TBP or imipenem, but not ETP or ceftazidime, often resulted in increased measurement of AmpC production. However, increased production of AmpC did not translate into increased MIC values. Finally, TBP showed potent activity against Enterobacterales with confirmed overproduction of AmpC. Table Disclosures Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Nicole Cotroneo, Spero Therapeutics (Employee, Shareholder) Ian A. Critchley, Ph.D., Spero Therapeutics (Employee, Shareholder) Brieanna Roth, n/a, Spero Therapeutics (Research Grant or Support) S J Ryan Arends, PhD, AbbVie (formerly Allergan) (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Castanheira, Mariana, Mariana Castanheira, Jennifer M. Streit, Helio S. Sader, and Dee Shortridge. "1238. Comparative Activity of Meropenem-Vaborbactam and Ceftazidime-Avibactam Against Multidrug-Resistant Enterobacter cloacae from Hospitals in Europe and United States." Open Forum Infectious Diseases 8, Supplement_1 (2021): S708—S709. http://dx.doi.org/10.1093/ofid/ofab466.1430.

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Abstract Background Enterobacter spp. are part of the ESKAPE pathogens that have been recognized as a threat to human health. Among this genus, E. cloacae species complex (ECL) is the most common species that causes human infections. ECL can develop resistance to ß-lactams and other antimicrobial classes due to alterations in gene regulatory pathways. We evaluated the activity of meropenem-vaborbactam, ceftazidime-avibactam, and comparator agents against 235 multidrug resistant (MDR) ECL isolates collected in Europe and the US during 2017-2019. Methods A total of 2,459 ECL clinical isolates were collected in 40 European and 33 US hospitals. Isolates were susceptibility tested by reference broth microdilution methods and results were interpreted using CLSI, EUCAST, and US FDA breakpoints. MDR was defined as resistant to 3 or more drug classes when applying the CLSI breakpoints. Results MDR ECL were observed among 9.6% of the overall isolates. The MDR rate in Europe (12.0%; 155/1,295) was considerably higher than in the US (6.9%; 80/1,164). Meropenem-vaborbactam inhibited 94.5% and 97.4% of the MDR ECL isolates applying CLSI and EUCAST breakpoints, respectively (Table). Meropenem inhibited 77.9%/85.5% of the isolates (CLSI/EUCAST breakpoints). Cefepime inhibited only 26.0%/16.2% of the MDR ECL isolates while piperacillin-tazobactam inhibited only 13.2%/6.4%. Ceftazidime-avibactam inhibited 93.6% of the MDR ECL isolates. Amikacin and tigecycline were the most active non-beta-lactam comparators, inhibiting 91.9% and 80.0% of these isolates using CLSI/US FDA breakpoints. A total of 93.1% of the isolates were intermediate to colistin applying CLSI breakpoints or susceptible using the EUCAST criteria. Meropenem-vaborbactam inhibited 73.5% and 87.8% of the MDR ECL isolates nonsusceptible to meropenem and cefepime, the main therapeutic option against ECL isolates. Ceftazidime-avibactam inhibited 73.5% of these isolates. Conclusion In a global surveillance, ECL is the second most common Enterobacterales species/species complex displaying MDR and carbapenem-resistance phenotypes, behind only Klebsiella pneumoniae. Meropenem-vaborbactam and ceftazidime-avibactam can be important options to treat infections caused by MDR ECL. Disclosures Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Jennifer M. Streit, BS, GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Dee Shortridge, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)

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Mendes, Rodrigo E., Jill Lindley, Nabina Gurung, et al. "1059. In vitro Activity of Exebacase (CF-301) against Staphylococcus aureus Causing Bacteremia in the United States, Including Multidrug-resistant Subsets." Open Forum Infectious Diseases 8, Supplement_1 (2021): S621—S622. http://dx.doi.org/10.1093/ofid/ofab466.1253.

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Abstract Background Exebacase (CF-301) is a lysin (peptidoglycan hydrolase enzyme) with anti-staphylococcal activity. CF-301 is in Phase 3 of clinical development for the treatment of Staphylococcus aureus (SA) bacteremia (SAB), including right-sided infective endocarditis (IE), used in addition to standard-of-care antibiotics. CF-301 in vitro activity was determined against SA isolates reflecting the Phase 3 target patient SAB population, including IE. Methods 666 SA recovered from blood (3% from known IE) of patients hospitalized in 29 centers located in 9 Census regions were included as part of the SENTRY Antimicrobial Surveillance Program for 2020. Identification was confirmed by MALDI-TOF. Susceptibility to 12 comparators used reference broth microdilution (BMD), whereas CF-301 used a modified BMD method with cation-adjusted Mueller-Hinton broth (CAMHB) supplemented with 25% horse serum and 0.5 mM DL-dithiothreitol according to CLSI. MIC interpretation for comparator agents used CLSI criteria, including determination of multidrug-resistant (MDR) phenotype (non-susceptible to ≥3 classes of antibiotics). Results Against all SA tested CF-301 had an MIC range of 0.06-1 mg/L, with MIC50, MIC90 and modal MIC values of 0.5 mg/L. CF-301 MIC results (MIC50/90, 0.5/0.5 mg/L) against methicillin-susceptible (MSSA) and -resistant (MRSA; 38.6% of all SA) SA were identical. Many comparators had activity against MSSA; among drugs indicated for treating SAB caused by MRSA, daptomycin and vancomycin were active (100% susceptible) against all isolates. A total of 62.3% of MRSA isolates were categorized as MDR, and CF-301 showed equal MIC50 and MIC90 results against MDR (MIC50/90, 0.5/0.5 mg/L) and non-MDR (MIC50/90, 0.5/0.5 mg/L) populations. Daptomycin and vancomycin were active (100% susceptible) against MDR MRSA isolates. Conclusion CF-301 was uniformly active against contemporary SA isolates responsible for bloodstream infections in the US in 2020. CF-301 activity was consistent, regardless of resistance phenotype (MSSA, MRSA, including MDR isolates). Surveillance data presented here further support the clinical development of CF-301 as a promising option for treatment of SAB, including those caused by MDR MRSA isolates. Disclosures Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Jill Lindley, Bravos Biosciences (Research Grant or Support)ContraFect Corporation (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support) Nabina Gurung, n/a, ContraFect Corporation (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Ray Schuch, PhD, ContraFect Corporation (Employee) Jane E. Ambler, PhD, ContraFect Corporation (Employee)

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Sader, Helio S., Leonard R. Duncan, Cheung Yee, et al. "1267. Five-Year Trend on the Susceptibility of Enterobacterales to Plazomicin and Other Aminoglycosides in Hospitals in the United States (2016–2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S721—S722. http://dx.doi.org/10.1093/ofid/ofab466.1459.

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Abstract Background Plazomicin (PLZ) is novel aminoglycoside (AMG) that was approved by the US FDA in June 2018 to treat complicated urinary tract infection (cUTI), including pyelonephritis. This agent is active against most isolates resistant to other AMGs. We evaluated PLZ activity against clinical isolates of Enterobacterales (ENT) from US hospitals. Methods 10,008 ENT isolates (1/patient) were collected from 35 US medical centers in 2016-2020 and susceptibility tested by the broth microdilution method at a central laboratory. PLZ breakpoints of ≤2/≥8 mg/L for susceptible [S]/resistant [R] (USFDA) were applied, and breakpoints established by the USFDA/CLSI, EUCAST and USCAST were applied to other AMGs for comparison. Isolates were mainly from cUTI (37.7%), bloodstream infection (24.9%), and pneumonia (20.3%). Results PLZ exhibited potent activity against ENT (MIC50/90, 0.5/1 mg/L), with S rates varying from 97.8% in 2016 to 95.8% in 2020 (96.8% overall). Against carbapenem-R ENT (CRE), S rates for PZL increased from 96.3% in 2016 to 100.0% in 2020 (Figure; 97.3% overall) and were markedly higher than amikacin (AMK; 75.2% overall), gentamicin (GEN; 48.7%), and tobramycin (TOB; 23.0%). The discrepancies between S rates for PLZ and other AMGs were greater when applying breakpoints generated using the same stringent contemporary methods applied to determine PLZ breakpoints. CRE S rates for AMK were 62.8% as per EUCAST and 52.2% as per USCAST. PLZ retained activity against GEN-non-S (NS; n=875; 90.6%S), TOB-NS (n=944; 92.7%S), and AMK-NS (n=60; 83.3%S) isolates. Among isolates from cUTI (n=3,774), 96.9% were PLZ-S, varying from 97.8% in 2017 to 95.8% in 2020. The ENT species most S to PLZ (lowest MIC values) were C. koseri (100.0%S), K. aerogenes (100.0%S), K. pneumoniae (99.8%S), and E. cloacae (99.7%S), which had MIC50/90 values of 0.25/0.5 mg/L, followed by K. oxytoca (MIC50/90, 0.5/0.5 mg/L; 99.9%S), E. coli (MIC50/90, 0.5/1 mg/L; 99.6%S), and C. freundii (MIC50/90, 0.5/1 mg/L; 100.0%S). Conclusion PLZ demonstrated potent activity against a large collection of contemporary ENT isolates from US hospitals with 4-fold lower MIC values than AMK. PLZ was markedly more active than AMK, GEN, or TOB against CRE and retained good activity against isolates NS to these AMGs. Disclosures Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Leonard R. Duncan, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Shionogi (Research Grant or Support) Cheung Yee, MSc, PhD, Cipla Therapeutics (Employee) Sandhya Das, n/a, Cipla Therapeutics (Employee) Jaideep Gogtay, n/a, Cipla Therapeutics (Employee)Cipla USA Inc. (Employee) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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37

Carvalhaes, Cecilia G., Abby L. Klauer, Paul R. Rhomberg, Michael A. Pfaller, Mariana Castanheira, and Mariana Castanheira. "1076. Activity of Rezafungin and Comparator Antifungal Agents Tested Against a Worldwide Collection of Contemporaneous Invasive Fungal Isolates (2019-2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S628. http://dx.doi.org/10.1093/ofid/ofab466.1270.

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Abstract Background Rezafungin (RZF) is a new echinocandin (ECH) with a long half-life and front-loaded drug exposure that allow for once-weekly intravenous administration. RZF is under Phase 3 development for the treatment of candidemia and invasive candidiasis and the prevention of invasive fungal disease caused by Candida, Aspergillus, and Pneumocystis spp. in blood and marrow transplant recipients. We evaluated the activity of RZF and comparators against invasive fungal isolates from the SENTRY Antimicrobial Surveillance Program. Methods A total of 1,427 Candida spp., 38 Cryptococcus neoformans (CNEO), 186 Aspergillus fumigatus (AFM), and 28 Aspergillus section Flavi (AFL) collected from 24 countries in 2019-2020 were tested. CLSI antifungal broth microdilution assays were performed according to standard method (M27, M38) with the exception that panels were made by dispensing 10 µL of a 20x drug stock solution into panels that contained 90 µL of RPMI and mixing. CLSI criteria were applied (M59, M60, M61). Results RZF demonstrated potent activity against C. albicans (CA; MIC50/90, 0.03/0.06 mg/L), C. tropicalis (CT; MIC50/90, 0.03/0.06 mg/L), C. glabrata (CG; MIC50/90, 0.06/0.06 mg/L), C. krusei (CK; MIC50/90, 0.03/0.03 mg/L), and C. dubliniensis (MIC50/90, 0.06/0.12 mg/L). RZF inhibited 99.6% of C. parapsilosis (CP; MIC50/90,1/2 mg/L) at ≤2 mg/L. RZF activity was similar to the other ECH against these 6 Candida spp. All CA, CT, and CK isolates as well as the majority of CG (96.2-97.9%) and CP (86.2-100%) isolates were susceptible (S) to comparator ECHs. Fluconazole resistance was detected among 0.5%, 4.5%, 10.5%, and 1.2% of CA, CG, CP, and CT, respectively. The azoles were active against CNEO, but all ECHs displayed limited activity against CNEO. ECHs were active against AFM (MEC90 range, 0.015-0.06 mg/L) and AFL (MEC90 range, 0.015-0.03 mg/L). RZF activity was similar to that of the other ECHs. All but 16 (8.6%) AFM isolates were S to voriconazole, and 100% of AFL were wild-type to mould-active azoles. Conclusion RZF and other ECHs displayed similar activity against Candida and Aspergillus spp. isolates from invasive fungal infections. These in vitro results support the development of RZF for the treatment and prevention of invasive fungal disease. Disclosures Cecilia G. Carvalhaes, MD, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support) Abby L. Klauer, n/a, Cidara Therapeutics, Inc. (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Paul R Rhomberg, Cidara Therapeutics, Inc. (Research Grant or Support)Pfizer, Inc. (Research Grant or Support) Michael A Pfaller, MD, Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Pfizer, Inc. (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Libby, Lawrence W. "Professional Diversity in Agricultural Economics: Salvation or Suicide?" Journal of Agricultural and Applied Economics 23, no. 1 (1991): 1–14. http://dx.doi.org/10.1017/s0081305200017751.

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The theme of my address is diversity in the profession of agricultural economics. I address diversity as a response, a strategy, not as an end in itself but as a conscious approach by ag economists in land grant universities seeking a useful role in the future.I chose this theme because I am genuinely concerned about our future in the 1862 and 1890 land grants. I acknowledge up front that not all ag economists work in land grant universities but all have a stake in them as our primary reservoir of human capital. Most practicing ag economists have roots in a land grant university and depend on their products for “new blood” in business or government. My interest in diversity has been influenced by the writings of several prominent ag economists, reviewed briefly below, by recent conversations with Jim Hildreth, John Holt, and Jim Bonnen regarding the future of the land grants and by personal observations of the painful manifestations of tensions within departments in the South and elsewhere as faculty try to position themselves for an uncertain future.

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Mendes, Rodrigo E., Timothy B. Doyle, Dee Shortridge, et al. "1232. In Vitro Activity of Cefiderocol and Comparator Agents against Molecularly characterized Carbapenem-resistant Enterobacterales Clinical Isolates Causing Infection in United States Hospitals (2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S705—S706. http://dx.doi.org/10.1093/ofid/ofab466.1424.

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Abstract:

Abstract Background Cefiderocol (CFDC) represents a new addition to the antimicrobial armamentarium with broad activity against Gram-negative bacteria (GNB). CFDC remains stable to hydrolysis in the presence of serine β-lactamases (ESBLs, KPC and OXA-type carbapenemases) and metallo-β-lactamases. The CFDC and comparator activities were analyzed against Enterobacterales (ENT), including molecularly characterized carbapenem-resistant isolates (CRE), as a part of the SENTRY Antimicrobial Surveillance Program in the USA. Methods 4,053 ENT were collected from 31 sites in 2020. Susceptibility testing was performed by broth microdilution and CFDC testing used iron-depleted media. CLSI/FDA breakpoints were used. Isolates displaying MIC values ≥4 µg/mL for imipenem (excluded for P. mirabilis, P. penneri and indole-positive Proteus) or meropenem (MER) were subjected to genome sequencing and screening of β-lactamase genes. Results A total of 36 (0.9%) CRE were detected, and represented mostly by isolates carrying blaKPC (75.0%; 27/36; Table). A small number of ENT (11.1%; 4/36) carried other carbapenemase genes (1 each of blaNDM-1, blaNDM-5, blaOXA-232, and blaSME-2), whereas 13.9% (5/36) of isolates did not carry any known carbapenemases. CFDC (99.8% susceptible [S]), imipenem-relebactam (IMR; 99.7-99.9%S), meropenem-vaborbactam (MEV; 99.9-100%S), ceftazidime-avibactam (CZA; 99.9-100%S), and MER (99.1-99.9%S) were active against all ENT and the non-CRE subset. CFDC (MIC50/90, 0.5/4 µg/mL; 97.2%S) and CZA (MIC50/90, 1/8 µg/mL; 94.4%S) were the most active agents against CRE, whereas CFDC, IMR, MEV and CZA were active (100%S) against the KPC subset. Finally, CFDC (MIC, 0.5-4 µg/mL; 100%S) was the most active agent against ENT carrying genes other than blaKPC, whereas CZA (1-8 µg/mL; 100%S) was most active against CRE with no known carbapenemases, followed by CFDC (0.5-8 µg/mL; 80.0%S). Conclusion The CFDC activity was consistent, regardless of phenotypes or genotypes, including against isolates carrying genes other than blaKPC, where approved β-lactam/β-lactamase inhibitor combinations showed limited activity. These data confirm CFDC as an important option for the treatment of infections caused by ENT and resistant subsets. Table Disclosures Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Timothy B. Doyle, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Dee Shortridge, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support) Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Jennifer M. Streit, BS, GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Mendes, Rodrigo E., Timothy B. Doyle, Dee Shortridge, et al. "1272. Cefiderocol In Vitro Activity Against Molecularly Characterized Acinetobacter baumannii-calcoaceticus Complex and Pseudomonas aeruginosa Clinical Isolates Causing Infection in United States Hospitals (2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S724—S725. http://dx.doi.org/10.1093/ofid/ofab466.1464.

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Abstract Background Cefiderocol (CFDC) is a novel siderophore-conjugated cephalosporin with broad activity against aerobic, nonfastidious Gram-negative bacteria. CFDC and comparator activities were analyzed against molecularly characterized A. baumannii-calcoaceticus complex (ACB) and P. aeruginosa (PSA), as a part of the SENTRY Antimicrobial Surveillance Program in the USA. Methods 248 ACB and 1,069 PSA were consecutively collected from 30 sites in 2020. Susceptibility was performed by broth microdilution and CFDC testing used iron-depleted media. FDA and CLSI breakpoints were used for CFDC. CLSI criteria were applied to comparators, except for imipenem-relebactam (IMR) that used FDA breakpoints. ACB and PSA with imipenem and/or meropenem (MER) MIC ≥4 μg/mL or ceftazidime (CAZ) and/or cefepime MIC ≥16 μg/mL were subjected to next-generation genome sequencing for screening for acquired extended-spectrum β-lactamase (ESBL) and carbapenemase genes. Results 33.0% of PSA met the MIC screening criteria, and ESBL or carbapenemase genes were not detected among these isolates, except for 1 strain with blaIMP-1. CFDC (97.7-100% susceptible [S]) had similar MIC50 (0.12 μg/mL) and MIC90 (0.25-0.5 μg/mL) values against both PSA populations, as did IMR (91.8-100%S). An MIC of 1 μg/mL was noted for CFDC against the single blaIMP-1-carrying isolate, whereas other agents had MIC values &gt;8 μg/mL (Table). CFDC (MIC50/90, 0.25/2 μg/mL) had the lowest MIC against ACB that met the MIC screening criteria, whereas CFDC, IMR, MER and CAZ were active (99.2-100%S) against MIC screen negative ACB. CFDC (MIC50/90, 0.25/2 μg/mL; 86.7-96.7%S) and IMR (MIC50/90, 0.25/1 μg/mL; 90.0%S) were the most active agents against ACB where only blaOXA-51 and variant genes were noted. CFDC was the only agent active (93.9-100%S; CLSI criteria) against ACB carrying blaOXA-23 (MIC50/90, 0.5/4 μg/mL), blaOXA-24 (MIC50/90, 0.25/1 μg/mL) or other genes (MIC50, 1 μg/mL). Conclusion Acquired ESBL and carbapenemase genes remained rare among multidrug-resistant PSA in USA hospitals, whereas acquired blaOXA carbapenemase were prevalent among ACB. CFDC showed potent activity against PSA subsets, as well as across molecularly characterized subsets of ACB, where treatment options were limited. Disclosures Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Timothy B. Doyle, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Dee Shortridge, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support) Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Jennifer M. Streit, BS, GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Sader, Helio S., Rodrigo E. Mendes, Cecilia G. Carvalhaes, Timothy B. Doyle, Mariana Castanheira, and Mariana Castanheira. "1068. Antimicrobial Activity of Aztreonam-Avibactam and Comparator Agents against Gram-Negative Bacteria Isolated from Bloodstream and Complicated Urinary Tract Infections in Europe, Asia, and Latin America (2019-2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S626—S627. http://dx.doi.org/10.1093/ofid/ofab466.1262.

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Abstract Background Aztreonam (ATM) is a monobactam stable to hydrolysis by metallo-β-lactamases (MBLs). Avibactam (AVI) is a non-β-lactam β-lactamase inhibitor that inhibits serine β-lactamases (BLs) such as ESBLs, KPCs, AmpC, and some OXAs. ATM-AVI is under clinical development for the treatment of serious infections caused by gram-negative bacteria (GNB), including MBL-producers. We evaluated ATM-AVI activity against GNB causing bloodstream (BSI) and complicated urinary tract infections (cUTI). Methods 10,103 GNB isolates (5,314 from BSI and 4,789 from cUTI) were consecutively collected (1/patient) from 66 medical centers located in Western Europe (W-EU; n=5,238; 25 centers in 10 countries), Eastern Europe (E-EU; n=1,729; 13 centers in 10 countries), the Asia-Pacific region (APAC; n=1,817; 17 centers in 9 countries), and Latin America (LATAM; n=1,319; 11 centers in 7 countries) in 2019 (n=5,030) and 2020 (n=5,073). Susceptibility (S) testing was performed by reference broth microdilution methods in a central laboratory. Results Overall, 99.9% of Enterobacterales (ENT; MIC50/90, ≤0.03/0.12 mg/L), including 99.7% of carbapenem-resistant ENT (CRE; MIC50/90, 0.25/0.5 mg/L), were inhibited at an ATM-AVI MIC of ≤8 mg/L (Table). CRE rates among BSI/cUTI isolates were 2.3%/0.6% in W-EU, 9.5%/6.1% in E-EU, 3.3%/2.8% in APAC, and 8.1%/5.2% in LATAM (4.2%/2.7% overall). ATM-AVI was very active against MDR (MIC50/90, 0.06/0.5 mg/L; 99.6% inhibited at ≤8 mg/L) and XDR (MIC50/90, 0.25/0.5 mg/L; highest MIC, 2 mg/L) ENT. Among P. aeruginosa, the percentage of isolates inhibited at ≤8 mg/L of ATM-AVI (78.3%) was similar to the S rates for piperacillin-tazobactam (78.8%), meropenem (79.1%), and ceftazidime (80.6%). Among S. maltophilia isolates, 100.0% were inhibited at ≤8mg/L of ATM-AVI and 95.4% were S to cotrimoxazole. ATM-AVI was highly active against Aeromonas spp. (highest MIC, 0.25 mg/L) and showed good activity against B. cepacia (MIC50/90, 4/16 mg/L). Conclusion ATM-AVI exhibited potent and consistent activity against ENT (including CRE, MDR, and XDR isolates) from W-EU, E-EU, APAC, and LATAM. Our results support clinical development of ATM-AVI to treat BSI and cUTI caused by ENT, P. aeruginosa, S. maltophilia, B. cepacia and Aeromonas spp. Table Disclosures Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Cecilia G. Carvalhaes, MD, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support) Timothy B. Doyle, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Sader, Helio S., Mariana Castanheira, Mariana Castanheira, et al. "217. Antimicrobial Activity of Dalbavancin against Gram-Positive Bacteria Isolated from Patients Hospitalized with Bacteremia in United States and European Medical Centers: Results from the International Dalbavancin Evaluation of Activity (IDEA) Program (2018-202)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S216—S217. http://dx.doi.org/10.1093/ofid/ofab466.419.

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Abstract Background The IDEA Program monitors the in vitro activity of dalbavancin and comparators against Gram-positive (GP) bacteria causing bloodstream infections (BSIs) and other infections in the United States (US) and Europe (EU). We evaluated the BSI results in 2018-2020. Methods 8,643 organisms were consecutively collected (1/patient) from 74 medical centers located in the US (n=4,544; 33 centers), western EU (W-EU; n=3,330; 28 centers from 10 nations: Belgium, France, Germany, Ireland, Italy, Portugal, Spain, Sweden, Switzerland, and the United Kingdom), and eastern EU (E-EU; n=769; 13 centers from 10 nations: Belarus, Czech Republic, Greece, Hungary, Israel, Poland, Romania, Russia, Slovenia, and Turkey). Organisms were susceptibility tested by reference broth microdilution methods in a central laboratory. Results Overall, the most common GP organisms were S. aureus (SA; 45.2%), E. faecalis (EF; 12.2%), S. epidermidis (SEP; 8.9%), β-hemolytic streptococci (BHS; 8.5%), and E. faecium (EFM; 7.6%), but rank order varied markedly by geographic region. The top 3 GP organisms were SA, EF, and BHS in the US; SA, EF, and EFM in W-EU; and SA, S. pneumoniae, and BHS in E-EU. Dalbavancin was highly active against methicillin-susceptible (MSSA) and -resistant (MRSA) SA, with an MIC90 of 0.03 mg/L in all 3 regions (Table). Among SA, MRSA rates were higher in the US (41.3%) than W-EU (21.5%) or E-EU (27.3%), and ceftaroline susceptibility ranged from 95.4% (W-EU) to 96.6% (US). Vancomycin (VAN) susceptibility varied from 97.3% (E-EU) to 98.3% (W-EU) among EF (97.5% in US), and dalbavancin was active against all VAN-S EF (MIC50/90, 0.03/0.06 mg/L; 100.0%S). Among SEP, all isolates were inhibited at ≤0.25 mg/L of dalbavancin (MIC50/90, 0.03/0.06 mg/L) and oxacillin resistance ranged from 66.9% in W-EU to 86.5% in E-EU (73.2% in US). BHS exhibited low dalbavancin MIC values (MIC50/90, 0.015/0.03 mg/L) and high S rates for its comparators. Among EFM, VAN-S rates varied from 36.6% in the US to 61.6% in E-EU and 76.1% in W-EU, and dalbavancin inhibited all VAN-S EFM at ≤0.25 mg/L (MIC50/90, 0.03/0.12 mg/L). Conclusion Dalbavancin exhibited potent activity and broad spectrum against a large collection of contemporary GP bacteria recovered from patients with BSI in US and EU. Disclosures Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Michael D. Huband, BS, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support) Dee Shortridge, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support) Cecilia G. Carvalhaes, MD, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support) Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support)

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Sader, Helio S., Mariana Castanheira, Mariana Castanheira, Cecilia G. Carvalhaes, S. J. Ryan Arends, and Rodrigo E. Mendes. "1305. Antimicrobial Activity of Ceftaroline and Comparator Agents against Ceftriaxone-Non-Susceptible Streptococcus pneumoniae from the United States (2008-2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S740—S741. http://dx.doi.org/10.1093/ofid/ofab466.1497.

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Abstract Background Ceftaroline (CPT) is a broad-spectrum cephalosporin with activity against S. pneumoniae (SPN), including multidrug-resistant (MDR) strains. CPT fosamil is approved for clinical use in the United States (US) to treat community-acquired bacterial pneumonia (CABP). We evaluated the activity of CPT against clinical isolates of ceftriaxone-non-susceptible (CRO-NS) SPN from US medical centers. Methods 21,750 SPN isolates were consecutively collected (1 per patient) from 201 medical centers in 2008-2020 and tested for susceptibility (S) to CPT and comparator agents using CLSI broth microdilution methods. Among these isolates, 1,419 (6.5%) were CRO-NS (CRO MIC ≥2 mg/L). Other resistant subgroups analyzed included MDR (NS to ≥3 classes of agents; n=4,454) and extensively drug resistant (XDR; NS to ≥5 classes; n=1,708) isolates. Results CRO susceptibility varied from 86.9% in 2009 to 98.8% in 2019 and increased from 89.0% in the 2008-2011 period to 98.1% in the 2018-2020 period. CPT was active against 99.9% of CRO-NS SPN (MIC50/90, 0.25/0.25 mg/L); only 1 isolate had a CPT MIC ≥0.5 mg/L. The CPT-NS isolate exhibited CPT and CRO MIC values of 1 and 8 mg/L, respectively, and had multiple substitutions in the penicillin binding proteins (PBP), mainly PBP2x, when compared with reference sequences. Also, it showed 31 amino acid alterations in MurM. The most active comparator agents against CRO-NS SPN were linezolid (MIC50/90, 0.5/1 mg/L; 100.0%S), levofloxacin (MIC50/90, 1/1 mg/L; 98.1%S), tigecycline (MIC50/90, ≤0.03/0.06 mg/L; 95.5%S), and vancomycin (MIC50/90, ≤1/≤1 mg/L; 100.0%S). Overall, 20.5% of isolates were MDR and 7.9% were XDR. MDR and XDR rates decreased from 24.4% and 13.5% in 2008-2011 to 16.8% and 2.4% in 2018-2020, respectively. CPT retained potent activity against MDR (MIC50/90, 0.12/0.25 mg/L; 99.9%S) and XDR (MIC50/90, 0.25/0.25 mg/L; 100.0%S) isolates; whereas CRO exhibited limited activity against both MDR (MIC50/90, 1/2 mg/L; 68.9%S) and XDR (MIC50/90, 2/2 mg/L; 26.7%S) isolate subsets. Among CRO-NS isolates, 97.7% were MDR and 88.2% were XDR. Conclusion CPT demonstrated potent and consistent activity over time (2008-2020) against a large collection of SPN from US medical centers, including CRO-NS, MDR, and XDR isolates. Disclosures Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Cecilia G. Carvalhaes, MD, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support) S J Ryan Arends, PhD, AbbVie (formerly Allergan) (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support)

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Sader, Helio S., Cecilia G. Carvalhaes, Rodrigo E. Mendes, Mariana Castanheira, and Mariana Castanheira. "200. Antimicrobial Activity of Ceftazidime-Avibactam and Comparators against AmpC Hyperproducing Enterobacterales and P. aeruginosa Collected from United States (US) Medical Centers (2016-2020)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S122—S123. http://dx.doi.org/10.1093/ofid/ofab466.200.

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Abstract Background E. cloacae species complex (ECL), S. marcescens (SM), C. freundii species complex (CF), and P. aeruginosa (PSA) are common pathogens in a variety of clinical infections. These organisms can overexpress the chromosomal AmpC that encodes resistance to several β-lactams. We evaluated the activity of ceftazidime-avibactam (CAZ-AVI) and comparators against these organisms. Methods 17,650 isolates, including 4,400 ECL, 2,074 SM, 1,644 CF, and 9,532 PSA, were consecutively collected from 88 US medical centers in 2016-2020. Among these isolates, 3,127 were ceftazidime-nonsusceptible (CAZ-NS; MIC ≥8 mg/L for Enterobacterales [ENT] and ≥16 mg/L for PSA) and considered probable AmpC hyperproducers. Isolates were susceptibility tested by broth microdilution method. Results Susceptibility to CAZ ranged from 73.6% (ECL) to 97.5% (SM; Table). Overall, 99.8% of ENT (99.7-99.9%) and 97.1% of PSA were CAZ-AVI-S; whereas 84.3% (79.0-97.7%) of ENT and 97.4% of PSA were ceftolozane-tazobactam (C-T)-S, 83.0% (78.5-94.8%) of ENT and 80.0% of PSA were piperacillin-tazobactam (PIP-TAZ)-S, and 98.4% (98.3-98.7%) of ENT and 79.5% of PSA were meropenem (MEM)-S. CAZ-AVI retained potent activity and broad spectrum against CAZ-NS ENT (n=1,629; MIC50/90, 0.5/1 mg/L; 99.0%S overall) and CAZ-AVI was more active than MEM (MIC50/90, 0.06/0.5 mg/L; 93.1%S) against these organisms. C-T (MIC50/90, 8/ &gt;16 mg/L; 23.8%S) and PIP-TAZ (MIC50/90, 64/ &gt;64 mg/L; 21.8%S) exhibited limited activity against CAZ-NS ENT. Among comparator agents, only amikacin (99.0%S), tigecycline (95.6%S), and imipenem (92.1%S) showed good activity against CAZ-NS ENT. Also, CAZ-AVI retained activity against 86.7% of ENT isolates that were NS to CAZ and MEM (n=113). CAZ-AVI (MIC50/90, 2/4 mg/L; 97.1%S) and C-T (MIC50/90, 0.5/2 mg/L; 97.4%S) were the most active compounds tested against PSA and both retained activity against CAZ-NS PSA. CAZ-AVI (MIC50/90, 4/16 mg/L; 81.8%S) and C-T (MIC50/90, 2/8 mg/L; 83.9%S) activity against CAZ-NS PSA was comparable to tobramycin (MIC50/90, 1/ &gt;8 mg/L; 82.2%S). Conclusion CAZ-AVI demonstrated potent activity and broad spectrum against AmpC hyperproducer organisms, such as ECL, SM, CF, and PSA, from US hospitals and remained highly active against CAZ-NS isolates. Disclosures Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Cecilia G. Carvalhaes, MD, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support) Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Mendes, Rodrigo E., Timothy B. Doyle, S. J. Ryan Arends, et al. "1075. In vitro Activity of Gepotidacin against Escherichia coli Causing Urinary Tract Infections in the United States, Including Molecularly Characterized Fluoroquinolone Resistant Subsets." Open Forum Infectious Diseases 8, Supplement_1 (2021): S629—S630. http://dx.doi.org/10.1093/ofid/ofab466.1269.

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Abstract Background Gepotidacin (GEP) is a novel bacterial type II topoisomerase inhibitor in Phase 3 clinical trials for the treatment of gonorrhea and uncomplicated urinary tract infections (UTI). This study characterized fluoroquinolone (FQ)-not susceptible (not S) E. coli causing UTI in U.S. patients and evaluated the in vitro activity of GEP and comparators against various drug resistance (R) subsets. Methods 1,035 E. coli collected from 38 U.S. sites were included as part of the GEP Global UTI Surveillance Program (2019). Isolates were tested for susceptibility by broth microdilution. E. coli with MICs ≥0.5 mg/L for ciprofloxacin (not S) and/or ≥1 mg/L for levofloxacin (not S) were selected for screening of FQ-R mechanisms, and subjected to genome sequencing, followed by screening of FQ-R genes and QRDR mutations in GyrA, GyrB, ParC and ParE. Results A total of 26.8% (277/1,035) E. coli met the screening criteria for FQ-not S (Table). Overall, GEP had MIC90 values of 2 mg/L and 4 mg/L against FQ-S and FQ-not S isolates, respectively. Nitrofurantoin had activity against the FQ-S and FQ-not S subsets (98.8% and 94.2%S, respectively), whereas amoxicillin-clavulanate (86.5% and 59.6%S) and trimethoprim-sulfamethoxazole (75.8% and 37.0%S) had limited activity. Most FQ-not S isolates (52.7%; 146/277) had double mutations in GyrA and ParC, followed by those isolates (20.6%; 57/277) with double mutations in GyrA and single mutations in ParC and ParE. The third most common genotype was represented by isolates (14.8%;41/277) with double mutations in GyrA and a single mutation in ParC. GEP had MIC50 values of 1 mg/L or 2 mg/L and MIC90 values of 2 mg/L or 4 mg/L when tested against isolates with various combinations of QRDR mutations. 4.3% (12/277) of FQ-not S E. coli carried qnrB (6) or qnrS (6), and GEP (MIC50/90, 8/16 mg/L) had MICs of 0.5–32 mg/L against this subset. Conclusion GEP demonstrated potent activity against FQ-S and FQ-not S E. coli causing UTI in the U.S. In addition, GEP MIC did not seem to be affected by any combinations of FQ-R genes and QRDR mutations tested, except against the rare presence of qnrB/S genes. These data support the clinical development of GEP as a treatment option for UTI caused by FQ-S and FQ-not S E. coli isolates. Table Disclosures Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Timothy B. Doyle, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) S J Ryan Arends, PhD, AbbVie (formerly Allergan) (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Deborah Butler, n/a, GlaxoSmithKline, LLC (Employee) Nicole Scangarella-Oman, MS, GlaxoSmithKline, LLC (Employee) Jennifer M. Streit, BS, GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support

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Sader, Helio S., Leonard R. Duncan, Mariana Castanheira, Mariana Castanheira, and Rodrigo E. Mendes. "238. Antimicrobial Activity of Dalbavancin against Gram-Positive Bacteria Isolated from Patients with Bone and Joint Infections from the United States (US) and Europe (2016-2020): Results from the International Dalbavancin Evaluation of Activity (IDEA) Program." Open Forum Infectious Diseases 8, Supplement_1 (2021): S228—S229. http://dx.doi.org/10.1093/ofid/ofab466.440.

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Abstract Background Bone and joint infections (BJI) comprise a series of disorders, including septic arthritis, osteomyelitis, and prosthetic joint infections. Dalbavancin (DALBA) is a lipoglycopeptide with a very long half-life that allows the treatment of serious infections with once weekly or biweekly administration. We evaluated the activity of DALBA against pathogens isolated from BJI. Methods A total of 798 organisms were collected from 62 US and 28 European (EU) hospitals in 2016-2020, including 503 S. aureus, 140 β-haemolytic streptococci (BHS), 71 coagulase-negative staphylococci (CoNS), 57 Enterococcus spp. (ESP), 22 viridans group streptococci (VGS), and 5 S. pneumoniae. Bacteria were identified by standard algorithms and MALDI-TOF-MS. Susceptibility testing was performed by the reference broth microdilution method in a central laboratory. Results S. aureus (63.0%) was the most common pathogen associated with BJI, followed by BHS (17.5%), CoNS (8.9%), and ESP (7.1%). All S. aureus isolates were susceptible (S) to DALBA (MIC50/90, 0.03/0.03 mg/L), linezolid (LNZ; MIC50/90, 1/2 mg/L), teicoplanin (TEI; MIC50/90, ≤0.5/1 mg/L), vancomycin (VAN; MIC50/90, 1/1 mg/L), and daptomycin (DAPTO; MIC50/90, 0.25/0.0.5 mg/L. DALBA was 8- to 16-fold more potent than DAPTO and 32- to 64-fold more potent than LNZ, VAN, and TEI against S. aureus. Oxacillin resistance (OXA-R) rates among S. aureus (MRSA rates) were 35.5% and 15.4% in the US and EU, respectively. Ceftaroline (CPT) was active against 98.6% of S. aureus (MIC50/90, 0.25/1 mg/L) and 94.7% of MRSA (MIC50/90, 1/1 mg/L) isolates. Doxycycline and levofloxacin were active against 97.0% and 76.5% of S. aureus, respectively. Among CoNS, (54.9% OXA-R), DALBA (MIC50/90, 0.03/0.03 mg/L; highest MIC, 0.12 mg/L) was the most potent agent, followed by DAPTO (MIC50/90, 0.25/0.5 mg/L), CPT (MIC50/90, 0.25/0.5 mg/L) and LNZ (MIC50/90, 0.5/1 mg/L). The highest DALBA MIC value among BHS and VGS was 0.12 mg/L (MIC90, 0.03 mg/L for both groups). VAN was active against 82.4% of ESP and DALBA inhibited all VAN-S ESP at ≤0.06 mg/L. Conclusion DALBA demonstrated potent in vitro activity against common gram-positive organisms (GP) causing BJI and appears to be a valuable option to treat BJI/osteomyelitis caused by GP. Disclosures Helio S. Sader, MD, PhD, FIDSA, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Leonard R. Duncan, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Basilea Pharmaceutica International, Ltd. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)Department of Health and Human Services (Research Grant or Support, Contract no. HHSO100201600002C)Shionogi (Research Grant or Support) Mariana Castanheira, PhD, AbbVie (formerly Allergan) (Research Grant or Support)Bravos Biosciences (Research Grant or Support)Cidara Therapeutics, Inc. (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Qpex Biopharma (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support) Mariana Castanheira, PhD, Affinity Biosensors (Individual(s) Involved: Self): Research Grant or Support; Allergan (Individual(s) Involved: Self): Research Grant or Support; Amicrobe, Inc (Individual(s) Involved: Self): Research Grant or Support; Amplyx Pharma (Individual(s) Involved: Self): Research Grant or Support; Artugen Therapeutics USA, Inc. (Individual(s) Involved: Self): Research Grant or Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; Basilea (Individual(s) Involved: Self): Research Grant or Support; Beth Israel Deaconess Medical Center (Individual(s) Involved: Self): Research Grant or Support; BIDMC (Individual(s) Involved: Self): Research Grant or Support; bioMerieux Inc. (Individual(s) Involved: Self): Research Grant or Support; BioVersys Ag (Individual(s) Involved: Self): Research Grant or Support; Bugworks (Individual(s) Involved: Self): Research Grant or Support; Cidara (Individual(s) Involved: Self): Research Grant or Support; Cipla (Individual(s) Involved: Self): Research Grant or Support; Contrafect (Individual(s) Involved: Self): Research Grant or Support; Cormedix (Individual(s) Involved: Self): Research Grant or Support; Crestone, Inc. (Individual(s) Involved: Self): Research Grant or Support; Curza (Individual(s) Involved: Self): Research Grant or Support; CXC7 (Individual(s) Involved: Self): Research Grant or Support; Entasis (Individual(s) Involved: Self): Research Grant or Support; Fedora Pharmaceutical (Individual(s) Involved: Self): Research Grant or Support; Fimbrion Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Fox Chase (Individual(s) Involved: Self): Research Grant or Support; GlaxoSmithKline (Individual(s) Involved: Self): Research Grant or Support; Guardian Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Hardy Diagnostics (Individual(s) Involved: Self): Research Grant or Support; IHMA (Individual(s) Involved: Self): Research Grant or Support; Janssen Research & Development (Individual(s) Involved: Self): Research Grant or Support; Johnson & Johnson (Individual(s) Involved: Self): Research Grant or Support; Kaleido Biosceinces (Individual(s) Involved: Self): Research Grant or Support; KBP Biosciences (Individual(s) Involved: Self): Research Grant or Support; Luminex (Individual(s) Involved: Self): Research Grant or Support; Matrivax (Individual(s) Involved: Self): Research Grant or Support; Mayo Clinic (Individual(s) Involved: Self): Research Grant or Support; Medpace (Individual(s) Involved: Self): Research Grant or Support; Meiji Seika Pharma Co., Ltd. (Individual(s) Involved: Self): Research Grant or Support; Melinta (Individual(s) Involved: Self): Research Grant or Support; Menarini (Individual(s) Involved: Self): Research Grant or Support; Merck (Individual(s) Involved: Self): Research Grant or Support; Meridian Bioscience Inc. (Individual(s) Involved: Self): Research Grant or Support; Micromyx (Individual(s) Involved: Self): Research Grant or Support; MicuRx (Individual(s) Involved: Self): Research Grant or Support; N8 Medical (Individual(s) Involved: Self): Research Grant or Support; Nabriva (Individual(s) Involved: Self): Research Grant or Support; National Institutes of Health (Individual(s) Involved: Self): Research Grant or Support; National University of Singapore (Individual(s) Involved: Self): Research Grant or Support; North Bristol NHS Trust (Individual(s) Involved: Self): Research Grant or Support; Novome Biotechnologies (Individual(s) Involved: Self): Research Grant or Support; Paratek (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): Research Grant or Support; Prokaryotics Inc. (Individual(s) Involved: Self): Research Grant or Support; QPEX Biopharma (Individual(s) Involved: Self): Research Grant or Support; Rhode Island Hospital (Individual(s) Involved: Self): Research Grant or Support; RIHML (Individual(s) Involved: Self): Research Grant or Support; Roche (Individual(s) Involved: Self): Research Grant or Support; Roivant (Individual(s) Involved: Self): Research Grant or Support; Salvat (Individual(s) Involved: Self): Research Grant or Support; Scynexis (Individual(s) Involved: Self): Research Grant or Support; SeLux Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Shionogi (Individual(s) Involved: Self): Research Grant or Support; Specific Diagnostics (Individual(s) Involved: Self): Research Grant or Support; Spero (Individual(s) Involved: Self): Research Grant or Support; SuperTrans Medical LT (Individual(s) Involved: Self): Research Grant or Support; T2 Biosystems (Individual(s) Involved: Self): Research Grant or Support; The University of Queensland (Individual(s) Involved: Self): Research Grant or Support; Thermo Fisher Scientific (Individual(s) Involved: Self): Research Grant or Support; Tufts Medical Center (Individual(s) Involved: Self): Research Grant or Support; Universite de Sherbrooke (Individual(s) Involved: Self): Research Grant or Support; University of Iowa (Individual(s) Involved: Self): Research Grant or Support; University of Iowa Hospitals and Clinics (Individual(s) Involved: Self): Research Grant or Support; University of Wisconsin (Individual(s) Involved: Self): Research Grant or Support; UNT System College of Pharmacy (Individual(s) Involved: Self): Research Grant or Support; URMC (Individual(s) Involved: Self): Research Grant or Support; UT Southwestern (Individual(s) Involved: Self): Research Grant or Support; VenatoRx (Individual(s) Involved: Self): Research Grant or Support; Viosera Therapeutics (Individual(s) Involved: Self): Research Grant or Support; Wayne State University (Individual(s) Involved: Self): Research Grant or Support Rodrigo E. Mendes, PhD, AbbVie (Research Grant or Support)AbbVie (formerly Allergan) (Research Grant or Support)Cipla Therapeutics (Research Grant or Support)Cipla USA Inc. (Research Grant or Support)ContraFect Corporation (Research Grant or Support)GlaxoSmithKline, LLC (Research Grant or Support)Melinta Therapeutics, Inc. (Research Grant or Support)Melinta Therapeutics, LLC (Research Grant or Support)Nabriva Therapeutics (Research Grant or Support)Pfizer, Inc. (Research Grant or Support)Shionogi (Research Grant or Support)Spero Therapeutics (Research Grant or Support)

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Beattie, Geoff. "The facts of life – research grants." PsyPag Quarterly 1, no. 97-5 (2015): 96–98. http://dx.doi.org/10.53841/bpspag.2015.1.97-5.96.

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Geoff Beattie is a Professor of Psychology at Edge Hill University and a Master’s supervisor on the Sustainability Leadership programme at the University of Cambridge. Best known for his work in non-verbal communication and body language, Geoff has also made a significant contribution to the psychology of sustainable consumption and implicit prejudice. This is evidenced in his success to obtain research grants, with a project on sustainable consumer behaviours funded by Tesco. Here, Geoff provides a narrative of his experiences with grant applications.

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Burke, Jack D., and Robert W. Light. "The Ben Franklin Challenge Grant Program." Industry and Higher Education 3, no. 1 (1989): 21–26. http://dx.doi.org/10.1177/095042228900300105.

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This paper describes and assesses the impact of one of the most successful and comprehensive industrial development and revitalization strategies in the USA, the state of Pennsylvania's Ben Franklin Partnership (BFP). Specifically, the focus is on the BFP's largest programme, the Challenge Grant for Technological Innovation. With the state government acting as a catalyst, the Challenge Grant Program joins together private industry and higher education to help create and retain industrial jobs and firms. The Challenge Grant Program is delivered through four university-based Advanced Technology Centres located across the state. The emphasis of the Challenge Grant Program is on joint industry-university research and development, advanced technology transfer, entrepreneurial assistance, and scientific education and advanced technology training.

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Jamieson, Kathleen Hall. "Reconceptualizing public engagement by land-grant university scientists." Proceedings of the National Academy of Sciences 117, no. 6 (2020): 2734–36. http://dx.doi.org/10.1073/pnas.1922395117.

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&NA;. "Indiana University Cancer Center Receives $500,000 Unrestricted Grant." Journal of Pediatric Hematology/Oncology 18, no. 1 (1996): 100. http://dx.doi.org/10.1097/00043426-199602000-00025.

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Journal articles on the topic 'Grant University'

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