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Journal articles on the topic 'Employee advisor'

Author: Grafiati

Published: 4 June 2021

Last updated: 9 February 2022

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1

Daar, Eric, Edwin DeJesus, Peter Ruane, et al. "Phase 3 Randomized, Controlled Trial of Switching to Fixed-dose Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Boosted Protease Inhibitor-based Regimens in Virologically Suppressed Adults: Week 48 Results." Open Forum Infectious Diseases 4, suppl_1 (2017): S735. http://dx.doi.org/10.1093/ofid/ofx180.003.

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Abstract Background Boosted protease inhibitor regimens (bPIs) are effective and often used in HIV-infected individuals with difficulties with adherence, but they can have drug–drug interactions and GI adverse effects. Bictegravir (B), a novel, potent integrase strand transfer inhibitor with a high barrier to resistance and low potential for drug–drug interactions, was coformulated with the recommended nucleoside reverse transcriptase inhibitor backbone emtricitabine (FTC)/tenofovir alafenamide (F/TAF) and demonstrated high efficacy and tolerability in randomized studies in treatment-naïve adu

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Tica, Jelena, Javier Ruiz Guiñazú, Charles P. Andrews, et al. "119. A Respiratory Syncytial Virus Prefusion F Protein (RSVPreF3) Candidate Vaccine Administered in Older Adults in a Phase I/II Randomized Clinical Trial Is Well Tolerated." Open Forum Infectious Diseases 7, Supplement_1 (2020): S187—S188. http://dx.doi.org/10.1093/ofid/ofaa439.429.

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Abstract Background RSV is a common cause of respiratory acute illness in older adults (OA). We evaluated safety and reactogenicity of RSVPreF3 candidate vaccine in young adults (YA) and OA. Methods In this phase I/II, placebo-controlled, multi-country trial (NCT03814590), YA aged 18–40 years were randomized 1:1:1:1 and received 2 doses of Low-, Medium- or High-dose of RSVPreF3 non-adjuvanted vaccine, or placebo, 2 months apart. Following favorable safety evaluation, a staggered enrolment with 2 steps followed in OA aged 60–80 years, who were randomized 1:1:1:1:1:1:1:1:1:1 to receive 1 of the

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Guiñazú, Javier Ruiz, Jelena Tica, Charles P. Andrews, et al. "121. A Respiratory Syncytial Virus Prefusion F Protein (RSVPreF3) Candidate Vaccine Administered in Older Adults in a Phase I/II Randomized Clinical Trial Is Immunogenic." Open Forum Infectious Diseases 7, Supplement_1 (2020): S188—S189. http://dx.doi.org/10.1093/ofid/ofaa439.431.

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Abstract Background RSV causes significant disease burden in older adults, since reinfections are common and may lead to severe disease presentations while only supportive treatment is available. We present immunogenicity of different formulations of an investigational vaccine (RSVPreF3) in young and older adults. Methods This is a phase I/II, placebo-controlled, multi-country trial (NCT03814590). Healthy adults aged 18–40 years were randomized 1:1:1:1 to receive 2 doses of either Low-, Medium- or High-dose of RSVPreF3 non-adjuvanted vaccine or placebo, 2 months apart. Following favorable safe

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Mills, Anthony, Gary J. Richmond, Cheryl Newman, et al. "116. Antiviral Activity and Safety of Long-acting Cabotegravir (CAB LA) Plus Long-acting Rilpivirine (RPV LA), Administered Every 2 Months (Q2M), in Hiv-positive Subjects: Results from the POLAR Study." Open Forum Infectious Diseases 7, Supplement_1 (2020): S186—S187. http://dx.doi.org/10.1093/ofid/ofaa439.426.

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Abstract Background Long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV) injectable suspensions have demonstrated efficacy in phase III studies. POLAR assessed antiviral activity and safety of CAB LA+RPV LA, administered every 2 mos (Q2M), in HIV-1 infected, antiretroviral therapy–experienced adults who completed LATTE and received once-daily oral CAB30mg+RPV25mg treatment. Methods POLAR is a phase IIb, multicenter, open-label, rollover study in 97 virologically suppressed, HIV-infected adults. LATTE participants who completed ≥312 weeks on study, with plasma HIV-1RNA&lt; 50c/mL at sc

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Andrew, Melissa K., Joon Hyung Kim, Sean Matthews, et al. "5. How Does Frailty Impact the Efficacy, Reactogenicity, Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine? A Secondary Analysis of the ZOE-50 and ZOE-70 Studies." Open Forum Infectious Diseases 7, Supplement_1 (2020): S2—S3. http://dx.doi.org/10.1093/ofid/ofaa417.004.

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Abstract Background Herpes zoster can negatively impact older adults’ health and quality of life. An adjuvanted recombinant zoster vaccine (RZV) has excellent vaccine efficacy (VE), including in older adults. Given that frailty is strongly associated with vulnerability to illness and adverse health outcomes, we studied how frailty impacts RZV VE, immunogenicity, reactogenicity, and safety. Methods In the ZOE-50 and ZOE-70 pivotal Phase 3 efficacy studies of RZV, 29,305 participants aged 50–96 received 2 doses of RZV vs. placebo in 1:1 randomization. In this secondary analysis (NCT03563183), a

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Walmsley, Sharon, Gary Richmond, Fritz Bredeek, et al. "Sword 1 and 2: Subgroup Analysis of 48 Week Results by Age, Race and Gender." Open Forum Infectious Diseases 4, suppl_1 (2017): S427. http://dx.doi.org/10.1093/ofid/ofx163.1078.

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Abstract Background Switching to the 2-drug regimen (2DR) of DTG+RPV was proven non-inferior to continuing a suppressive PI-, INI- or NNRTI- based current antiretroviral regimen (CAR) at Week 48. This analysis evaluated the efficacy and safety of switching from CAR to DTG+RPV by age, race and gender subgroups. Methods Two identically designed, open-label, multicenter, global, phase III, non-inferiority studies compared the efficacy and safety of switching from a 3 or 4-drug CAR to DTG + RPV once daily in HIV-1-infected adults, with HIV-1 RNA&lt;50 c/mL. Primary endpoint was proportion of p

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Orkin, Chloe, Jean-Michel Molina, Joel Gallant, et al. "Week 48 Results of EMERALD: A Phase 3, Randomized, Non-inferiority Study Evaluating the Efficacy and Safety of Switching from Boosted-protease Inhibitors (bPI) Plus Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) Regimens to the Once Daily (QD), Single-tablet Regimen (STR) of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Virologically Suppressed, HIV-1-infected Adults." Open Forum Infectious Diseases 4, suppl_1 (2017): S737—S738. http://dx.doi.org/10.1093/ofid/ofx180.009.

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Abstract Background EMERALD is evaluating the efficacy and safety of switching from bPI + FTC/TDF regimens (control) to D/C/F/TAF 800/150/200/10 mg in virologically suppressed, HIV-1-infected adults. We present Week 48 primary results. Method EMERALD (NCT02269917) is a randomized, active-controlled, open-label, international, multicenter, parallel-group, non-inferiority trial. Virologically suppressed (viral load [VL] &lt; 50 c/mL for ≥2 months), HIV-1-infected adults were randomized (2:1) to switch to D/C/F/TAF or continue control. The FDA-stipulated primary endpoint was non-inferiority o

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Marty, Francisco M., Prashant Malhotra, Robert L. Gottlieb, et al. "72. Remdesivir vs Standard Care in Patients with Moderate covid-19." Open Forum Infectious Diseases 7, Supplement_1 (2020): S166—S167. http://dx.doi.org/10.1093/ofid/ofaa439.382.

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Abstract Background Remdesivir (RDV) shortens time to recovery time in patients with severe COVID-19. Its effect in patients with moderate COVID-19 remains unclear. Methods We conducted an open-label, phase 3 trial (NCT04252664) involving hospitalized patients with confirmed SARS-CoV-2 infection, evidence of pulmonary infiltrates, and oxygen saturation &gt;94% on room air. Patients were randomly assigned 1:1:1 to receive up to 5d or 10d of RDV with standard of care (SoC), or SoC alone; patients could be discharged prior to completing per-protocol assigned treatment duration. RDV was dosed

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Chen, Donald, Liyi Xu, Mary Fortunato-Habib, et al. "1248. Genomic Sequencing and Clinical Data Integration for Next-Generation Infection Prevention." Open Forum Infectious Diseases 5, suppl_1 (2018): S379—S380. http://dx.doi.org/10.1093/ofid/ofy210.1081.

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Abstract Background Typical Infection Prevention to detect pathogen transmission in hospitals has relied on observation of (1) uncommon pathogen phenotypes or (2) greater than expected number of pathogen phenotypes in a given timeframe and/or location. Genome sequencing of targeted organisms in conjunction with routine patient geo-temporal information and antibiotic susceptibility data holds promise in identifying transmissions with greater sensitivity and specificity, saving time and effort in reviewing for transmission events. Methods In an on-going genomic sequencing surveillance effort in

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Diaz, George, Jose Ramon Arribas, Jose Ramon Arribas, et al. "73. Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated with Remdesivir." Open Forum Infectious Diseases 7, Supplement_1 (2020): S167. http://dx.doi.org/10.1093/ofid/ofaa439.383.

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Abstract Background Remdesivir (RDV), a RNA polymerase inhibitor with potent in vitro activity against SARS-CoV-2, is the only treatment with demonstrated efficacy in shortening the duration of COVID-19. Here we report regional differences in clinical outcomes of severe COVID-19 patients treated with RDV, as part of an open-label, randomized phase-3 trial establishing RDV treatment duration. Methods Hospitalized patients with oxygen saturation ≤94%, a positive SARS-CoV-2 PCR in the past 4 days and radiographic evidence of pneumonia were randomized 1:1 to receive 5d or 10d of intravenous RDV. W

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Sakila, Kevin Luhika. "Pengaruh Kepuasan Kerja, Affective Commitment, Continuance Commitment, dan Normative Commitment terhadap Turnover Intention Karyawan Grand Palace Hotel Malang." Ekonomi Bisnis 24, no. 1 (2019): 31. http://dx.doi.org/10.17977/um042v24i1p31-42.

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ABSTRACT Sakila, Kevin Luhika. 2018. The Influence of Job Satisfaction, Affective Commitment, Continuance Commitment, and Normative Commitment to Employee Intention Turnover Grand Palace Hotel Malang. Sarjana's Thesis, Department of Management, Faculty of Economics, Universits Negeri Malang. Advisor: Lohana Juariyah, S.E., M.Si KEY WORDS: Job Satisfaction, Affective Commitment, Continuance Commitment, Normative Commitment, Employee Turnover Intention The hospitality industry is one of the industries that often experience employee turnover problems. Basically, to know the factors causing someon

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Emery, P., Y. Tanaka, V. Bykerk, et al. "SAT0104 MAINTENANCE OF SDAI REMISSION AND PATIENT-REPORTED OUTCOMES (PROS) FOLLOWING DOSE DE-ESCALATION OF ABATACEPT IN MTX-NAÏVE, ANTI-CITRULLINATED PROTEIN ANTIBODY (ACPA)+ PATIENTS WITH EARLY RA: RESULTS FROM AVERT-2, A RANDOMISED PHASE IIIB STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 985.1–986. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1429.

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Background:The Phase IIIbAssessingVeryEarlyRATreatment (AVERT)-2 trial (NCT02504268) evaluated SC abatacept (ABA) + MTX vs ABA placebo (PBO) + MTX in ACPA+ patients (pts) with early, active RA.1Results from the 56-wk induction period (IP) showed a significantly greater proportion of pts treated with ABA + MTX (vs MTX alone) reported clinically meaningful improvements in HAQ-DI, global disease activity and pain, which were sustained at 52 wks.2Objectives:To report maintenance of SDAI remission and PROs from the AVERT-2 de-escalation (D-E) period.Methods:Pts received blinded SC ABA (125 mg once

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Boeckh, Michael, Ann Arvin, Kathleen Mullane, et al. "Immunogenicity of Inactivated Varicella Zoster Vaccine (ZVIN) in Autologous Hematopoietic Stem Cell Transplant (auto-HSCT) Recipients." Open Forum Infectious Diseases 4, suppl_1 (2017): S60. http://dx.doi.org/10.1093/ofid/ofx162.141.

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Abstract Background Recipients of auto-HSCT have an increased risk of herpes zoster (HZ) infection; however, live attenuated varicella-zoster virus (VZV) vaccine is contraindicated in these patients. In this pivotal Phase III study (V212-001; NCT01229267) inactivated VZV vaccine (ZVIN) reduced the rate of HZ infection compared with placebo (estimated vaccine efficacy, 63.8%) and was well tolerated. Immunogenicity of ZVINin recipients of auto-HSCT was assessed in the Phase III study as an exploratory objective. Methods Adults undergoing auto-HSCT were randomized to receive either ZVIN(n = 560)

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Brar, Indira, Peter Ruane, Douglas Ward, et al. "1028. Long-term Follow-up After a Switch to Bictegravir, Emtracitabine, Tenofovir Alafenamide from Dolutegravir, Abacavir, Lamivudine." Open Forum Infectious Diseases 7, Supplement_1 (2020): S543—S544. http://dx.doi.org/10.1093/ofid/ofaa439.1214.

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Abstract Background Bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) is a guidelines-recommended single-tablet regimen (STR) for people living with HIV-1 (PLWH). Week (W) 48 primary endpoint results of this phase 3 study switching to B/F/TAF from dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) established the safety and efficacy of B/F/TAF. Here we report outcomes from an open-label (OL) extension of B/F/TAF. Methods Adults virologically suppressed on DTG, ABC, and 3TC were randomized 1:1 to switch to B/F/TAF once daily or continue their current regimen as a STR in a doub

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Groll, Andreas H., Hisham Abdel-Azim, Thomas Lehrnbecher, et al. "Safety, Tolerability, and Pharmacokinetics (PK) of Posaconazole (POS) Intravenous (IV) Solution and Oral Powder for Suspension in Children With Neutropenia." Open Forum Infectious Diseases 4, suppl_1 (2017): S296. http://dx.doi.org/10.1093/ofid/ofx163.681.

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Abstract Background POS, a triazole antifungal approved for prophylaxis and treatment of adults with invasive fungal infections, is available as an IV solution and 2 oral formulations: an oral suspension and a tablet with improved bioavailability. A novel powder for oral suspension (PFS) has been developed to offer the bioavailability of the tablet in a formulation optimized for weight-based dosing in children. The objective of this study is to evaluate the safety, tolerability, and PK of POS IV and POS PFS in pediatric patients (patients) aged 2 to 17 y with documented or expected neutropenia

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Emery, P., M. Ǿstergaard, L. C. Coates, et al. "THU0373 SECUKINUMAB DOSE ESCALATION ON ACR RESPONSES IN ANTI-TUMOUR NECROSIS FACTOR NAÏVE PATIENTS WITH PSORIATIC ARTHRITIS: 2-YEAR DATA FROM THE PHASE 3 FUTURE 4 AND FUTURE 5 STUDIES." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 418.1–419. http://dx.doi.org/10.1136/annrheumdis-2020-eular.287.

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Background:Secukinumab (SEC) 150 and 300 mg doses are approved for the treatment of psoriatic arthritis (PsA). SEC 300 mg is the recommended dose for patients (pts) with concomitant moderate-to-severe plaque psoriasis or who are anti-tumour necrosis factor (TNF) inadequate responders. An increase from 150 mg to 300 mg has been reported to be beneficial in some patients with a suboptimal response to SEC 150 mg.1Here, we present a post hoc analysis in anti-TNF naïve pts who escalated from SEC 150 to 300 mg dose in two Phase 3 studies, FUTURE 4 (NCT02294227) and FUTURE 5 (NCT02404350).Objectives:

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Katsube, Takayuki, Nao Kawaguchi, Yuko Matsunaga, et al. "1316. Pharmacokinetic/Pharmacodynamic Analyses of Cefiderocol in Critically Ill Patients." Open Forum Infectious Diseases 7, Supplement_1 (2020): S669—S670. http://dx.doi.org/10.1093/ofid/ofaa439.1498.

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Abstract Background Cefiderocol (CFDC), a novel siderophore cephalosporin, has demonstrated potent antibacterial activity against a wide range of Gram-negative bacteria including carbapenem-resistant strains. We aimed to evaluate relationships between drug exposure and outcomes in critically ill patients. Methods Sparse pharmacokinetic (PK) samples at steady state from critically ill patients with pneumonia, bloodstream infection/sepsis, or complicated urinary tract infection receiving CFDC in two Phase 3 studies were analyzed. Percent time of dosing interval of free drug concentration exceedi

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Ait-Khaled, Mounir, Choy Man, Jorg Sievers, et al. "1024. Impact of Treatment Adherence on Efficacy of DTG/3TC and DTG + TDF/FTC: Pooled Analysis of the GEMINI 1 and 2 Clinical Trials." Open Forum Infectious Diseases 7, Supplement_1 (2020): S541—S542. http://dx.doi.org/10.1093/ofid/ofaa439.1210.

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Abstract Background GEMINI 1 & 2 are global double-blind, multi-center phase III non-inferiority studies evaluating efficacy and safety of dolutegravir (DTG) + lamivudine (3TC) once daily in treatment-naive HIV-1-infected adults with Screening HIV-1 RNA ≤ 500,000 c/mL (ClinicalTrials.gov: NCT02831673/NCT02831764). Participants were randomized 1:1 to treatment with DTG+3TC or DTG + tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC). The primary endpoint was the proportion of participants with plasma HIV-1 RNA &lt; 50 c/mL at Week 48 (Snapshot algorithm). DTG+3TC was non-inferior to

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Hagins, Debbie, Princy Kumar, Michael Saag, et al. "1046. Week 48 Outcomes from the BRAAVE 2020 Study: A Randomized Switch to B/F/TAF in African American Adults with HIV." Open Forum Infectious Diseases 7, Supplement_1 (2020): S552—S553. http://dx.doi.org/10.1093/ofid/ofaa439.1232.

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Abstract Background Black Americans are disproportionately impacted by HIV. The BRAAVE 2020 study, evaluated the safety and efficacy of switching to the guidelines-recommended single-tablet regimen bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) in Black adults through week (W) 48. Methods Adults with HIV who self-identified as Black or African American and were virologically suppressed on 2 NRTIs plus a 3rd agent were randomized (2:1) to switch to open-label B/F/TAF once daily or stay on their baseline regimen (SBR). Prior virologic failure was allowed except failure on an INSTI.

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Golan, Yoav, Herbert L. DuPont, Fernando Aldomiro, Erin H. Jensen, Mary E. Hanson, and Mary Beth Dorr. "Bezlotoxumab (BEZ) for Prevention of Clostridium Difficile Infection (CDI) Recurrence (rCDI): Outcomes in Patients with Substantial Renal Impairment (SRI)." Open Forum Infectious Diseases 4, suppl_1 (2017): S387. http://dx.doi.org/10.1093/ofid/ofx163.962.

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Abstract Background CDI in patients with SRI is harder to treat and is associated with higher recurrence. MODIFY I/II found that BEZ, a monoclonal antibody against C. difficile toxin B, is superior to placebo (PBO) at preventing rCDI in patients receiving standard of care antibiotics (SoC). This post hoc analysis assessed efficacy of BEZ in patients with SRI in the MODIFY studies. Methods MODIFY I/II mITT populations were pooled to estimate initial clinical cure (ICC), rCDI, and mortality through 12 weeks. Estimated glomerular filtration rate (eGFR) was calculated with the Modified Diet in Ren

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Goggin, Kathryn, Yuki Inaba, Veronica Gonzalez-Pena, et al. "1756. Prediction of Bloodstream Infection Prior to Onset of Symptoms by Plasma Metagenomic Sequencing in Pediatric Patients With Relapsed or Refractory Malignancy (PREDSEQ)." Open Forum Infectious Diseases 5, suppl_1 (2018): S60. http://dx.doi.org/10.1093/ofid/ofy209.141.

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Abstract Background Patients undergoing treatment for relapsed or refractory malignancies are at high risk of life-threatening bloodstream infection (BSI). A predictive screening test for BSI might allow pre-emptive therapy, but no validated test is currently available. We tested the hypothesis that plasma metagenomic next generation pathogen sequencing (NGS) would predict BSI before the onset of attributable symptoms. Methods We enrolled 31 pediatric patients receiving for treatment relapsed or refractory malignancy in an IRB-approved prospective cohort study (PREDSEQ) of predictive sequencin

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Wohl, David A., Yazdan Yazdanpanah, Axel Baumgarten, et al. "LB4. A Phase 3, Randomized, Controlled Clinical Trial of Bictegravir in a Fixed-Dose Combination, B/F/TAF, vs. ABC/DTG/3TC in Treatment-Naïve Adults at Week 96." Open Forum Infectious Diseases 5, suppl_1 (2018): S760—S761. http://dx.doi.org/10.1093/ofid/ofy229.2178.

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Abstract Background Bictegravir (B), a potent INSTI with a high barrier to resistance, is coformulated with emtricitabine (F) and tenofovir alafenamide (TAF) as the FDA-approved single-tablet regimen B/F/TAF. We report Week 96 results from an ongoing phase 3 study comparing B/F/TAF to coformulated dolutegravir, abacavir, and lamivudine (DTG/ABC/3TC) in treatment-naïve adults living with HIV-1. Primary outcome at W48 demonstrated noninferior virologic responses, similar bone and renal profiles, and no viral resistance. Methods We randomized 1:1 HLA-B*5701-negative adults, without HBV and with e

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Eron, Joseph J., Aimee Wilkin, Moti Ramgopal, et al. "1002. A Daily Single Tablet Regimen (STR) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Virologically-Suppressed Adults Living with HIV and End Stage Renal Disease on Chronic Hemodialysis." Open Forum Infectious Diseases 7, Supplement_1 (2020): S529—S530. http://dx.doi.org/10.1093/ofid/ofaa439.1188.

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Abstract Background Treatment for people living with HIV (PLWH) and end stage renal disease (ESRD) on hemodialysis (HD) has previously required complex dose-adjusted regimens. We evaluated a daily regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) and established this treatment as effective and safe, showing that daily TAF resulted in lower plasma tenofovir exposure than a historical comparison of once weekly tenofovir disoproxil fumarate in patients with ESRD on HD. After week (W) 96, participants transitioned to daily B/F/TAF to assess whether efficacy and saf

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Smith, Graham, Keith Henry, Daniel Podzamczer, et al. "638. Safety, Efficacy, and Durability of Long-Acting CAB and RPV as Maintenance Therapy for HIV-1 Infection: LATTE-2 Week 256 Results." Open Forum Infectious Diseases 7, Supplement_1 (2020): S379—S380. http://dx.doi.org/10.1093/ofid/ofaa439.832.

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Abstract Background Long-acting (LA) injectable suspensions of cabotegravir (CAB) & rilpivirine (RPV) are in phase III development. LATTE-2 W160 results demonstrated high rates of virologic response & overall tolerability. This W256 analysis evaluated long-term efficacy, safety, & tolerability of every 8-week (Q8W) & 4-week (Q4W) intramuscular (IM) dosing. Methods LATTE-2 is a phase IIb, multicenter, parallel arm, open-label study in antiretroviral therapy–naive adults with HIV. After a 20-week Induction Period on oral CAB+abacavir/lamivudine, participants (pts) with plasma HIV

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Jackson, Edward, Piyali Chatterjee, Susan Smith, Karen Badal, and David E. Griffith. "1330. Diagnosis and Management of NTM Lung Disease: Effect of Online Educational Interventions on Infectious Disease Specialist Knowledge." Open Forum Infectious Diseases 5, suppl_1 (2018): S406. http://dx.doi.org/10.1093/ofid/ofy210.1163.

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Abstract Background Diagnosis and management of nontuberculous mycobacterial (NTM) lung disease is challenging for clinicians due to its rarity and the need for complicated, multidrug antibiotic regimens. The objective of this study was to determine whether online educational interventions can effectively address knowledge gaps among ID specialists regarding diagnosis and treatment of patients with NTM lung disease. Methods Two educational interventions, consisting of a text-based activity with interactive questions, and a video-based discussion between two experts, were developed and made ava

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Smolen, J. S., P. Emery, W. Rigby, et al. "THU0213 UPADACITINIB AS MONOTHERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS AND PRIOR INADEQUATE RESPONSE TO METHOTREXATE: RESULTS AT 84 WEEKS FROM THE SELECT-MONOTHERAPY STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 331.2–332. http://dx.doi.org/10.1136/annrheumdis-2020-eular.961.

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Background:In the SELECT-MONOTHERAPY trial, upadacitinib (UPA), an oral JAK inhibitor, demonstrated significantly greater efficacy compared to continuing methotrexate (MTX) when used as monotherapy over 14 weeks (wks) in patients (pts) with rheumatoid arthritis (RA) and prior inadequate response to MTX.1Objectives:To describe the long-term safety and efficacy of UPA monotherapy in an ongoing long-term extension (LTE) of the SELECT-MONOTHERAPY trial.Methods:Pts on stable MTX were randomized to either continue MTX (cMTX, given as blinded study drug) or switch to once-daily (QD) UPA 15 (UPA15) or

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Emery, P., Y. Tanaka, V. Bykerk, et al. "FRI0090 MAINTENANCE OF CLINICAL RESPONSE WITH ABATACEPT IN COMBINATION WITH MTX IN INDIVIDUAL PATIENTS WITH EARLY RA WHO ARE MTX-NAÏVE AND ANTI-CITRULLINATED PROTEIN ANTIBODY (ACPA)+: RESULTS FROM THE INDUCTION PERIOD OF AVERT-2, A RANDOMISED PHASE IIIB STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 623.2–623. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2367.

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Background:In the 56-wk induction period (IP) of the Phase IIIbAssessingVeryEarlyRATreatment (AVERT)-2 trial (NCT02504268), more patients (pts) achieved SDAI remission (≤3.3) with abatacept (ABA) + MTX vs ABA placebo (PBO) + MTX at IP Wk 52.1It is unknown whether each individual pt within a treatment (Tx) group achieves and sustains the same efficacy endpoints at all time points during the IP.Objectives:To investigate whether ABA effectiveness is sustained by individual pts who achieved SDAI remission (≤3.3), SDAI low disease activity (LDA; >3.3–11), DAS28 (CRP) <2.6, ACR50/70 response o

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Febriantoro, Krisna. "The Effect of Perceived Organizational Support and Job Satisfaction on Employees Performance of Administration and Finance Department at Kebon Agung Sugar Factory Malang through Organizational Commitment as an Intervening Variable." Ekonomi Bisnis 23, no. 2 (2018): 81. http://dx.doi.org/10.17977/um042v23i2p81-90.

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ABSTRACTFebriantoro, Krisna. 2018. The Effect of Perceived Organizational Support and Job Satisfaction on Employees Performance of Administration and Finance Department at Kebon Agung Sugar Factory Malang through Organizational Commitment. Sarjana’s Thesis, Department of Management, Faculty of Economics, Universitas Negeri Malang. Advisor: Lohana Juariyah, S.E., M.SiKeywords: Perceived Organizational Support, Job Satisfaction, Organizational Commitment, PerformanceHuman Resources is one of the most important resources for the establishment of a company. Therefore, the ability to manage the per

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Nance, Robin, Vani Vannappagari, Kimberly Smith, et al. "Viral Failure Among Persons Living with HIV Initiating Dolutegravir-Based vs. Other Recommended Regimens in Real-World Clinical Care Settings." Open Forum Infectious Diseases 4, suppl_1 (2017): S39. http://dx.doi.org/10.1093/ofid/ofx162.095.

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Abstract Background Much of the prior research on viral failure (VF) with integrase inhibitor (INSTI) therapy is based on results from trials rather than clinical care settings and little is known about recently approved medications such as dolutegravir (DTG). We compared VF in persons living with HIV (PLWH) who initiated DTG-based vs. other guideline recommended regimens in clinical care across the United States. Methods PLWH from eight CFAR Network of Integrated Clinical Systems (CNICS) sites who started a recommended regimen between August 2013 and August 2016 were included. We compared DTG

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Arribas, Jose Ramon, Jose Ramon Arribas, Arun J. Sanyal, et al. "557. Impact of Concomitant Hydroxychloroquine Use on Safety and Efficacy of Remdesivir in Moderate COVID-19 Patients." Open Forum Infectious Diseases 7, Supplement_1 (2020): S343—S344. http://dx.doi.org/10.1093/ofid/ofaa439.751.

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Abstract Background Remdesivir (RDV) has been shown to shorten recovery time and was well tolerated in patients with severe COVID-19. Hydroxychloroquine (HQN) is an experimental treatment for COVID-19. Effects of coadministration of HQN with RDV have not been studied and are relevant given the long half-life (~22 days) of HQN. We report the impact of concomitant HQN and RDV use on clinical outcomes and safety in patients with moderate COVID-19. Methods We enrolled hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation &gt;94% on room air, and radiological evidence of

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Kinoshita, David PatersonDavid PatersonMasahiro, Kiichiro Toyoizumi, Yuko Matsunaga, and Roger Echols. "1285. Outcomes in Patients with Gram-Negative Bacteremia from Phase 2 and Phase 3 Clinical Trials of Cefiderocol, a Novel Siderophore Cephalosporin." Open Forum Infectious Diseases 7, Supplement_1 (2020): S658. http://dx.doi.org/10.1093/ofid/ofaa439.1468.

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Abstract Background Cefiderocol (CFDC) is the first siderophore cephalosporin approved (US and EU) for a broad range of infections caused by Gram-negative (GN) bacteria, including carbapenem-resistant Enterobacterales (ENT) and non-fermenters (NFs). Bacteremia is a serious manifestation of GN infection and understanding how well an antibiotic works to clear the bacteremia is an important part of drug evaluation. Methods All completed clinical studies for CFDC development were used to identify patients with GN bacteremia. Information collected included the primary infection site, species identi

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Mills, Anthony, Elizabeth A. Martin, Chih-Chin Liu, Martine Drolet, and Peter Sklar. "1011. Efficacy and Safety of Doravirine in Treatment-Naïve Adults ≥50 Years Old With HIV-1." Open Forum Infectious Diseases 7, Supplement_1 (2020): S533—S534. http://dx.doi.org/10.1093/ofid/ofaa439.1197.

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Abstract Background Nearly 50% of people living with HIV in the US are ≥50 years old. Older people are more likely to have late-stage HIV infection at diagnosis, greater risk for cardiovascular disease and certain cancers, and concurrent medications for common age-related conditions. Doravirine (DOR) is a next-generation NNRTI with activity against first-generation NNRTI-associated mutations, a neutral impact on lipids, and few drug-drug interactions with commonly used medications. Methods We compared Week 96 results from DOR Phase 2 and Phase 3 trials (P007, P018, and P021) in treatment-naïve

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Ison, Michael G., Simon Portsmouth, Yuki Yoshida, Takao Shishido, Frederick Hayden, and Takeki Uehara. "LB16. Phase 3 Trial of Baloxavir Marboxil in High-Risk Influenza Patients (CAPSTONE-2 Study)." Open Forum Infectious Diseases 5, suppl_1 (2018): S764—S765. http://dx.doi.org/10.1093/ofid/ofy229.2190.

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Abstract Background Baloxavir marboxil (BXM), an oral selective cap-dependent endonuclease inhibitor, is effective and safe for treating acute influenza in otherwise healthy patients. Method We conducted an international, randomized, double-blind, placebo (PLC)- and oseltamivir (Os)-controlled treatment study in patients at higher risk (HR) of influenza complications. Inclusion criteria included age ≥12 years, fever + influenza symptoms of ≤48 hours duration, and presence of at least 1 HR factor adapted from CDC criteria. Patients were randomized (1:1:1) to a single oral dose of BXM (40/80 mg

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Abrahamian, Fredrick M., George Sakoulas, Evan Tzanis, et al. "1347. Omadacycline for Acute Bacterial Skin and Skin Structure Infections: Integrated Analysis of Randomized Clinical Trials." Open Forum Infectious Diseases 5, suppl_1 (2018): S412. http://dx.doi.org/10.1093/ofid/ofy210.1178.

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Abstract Background Skin infections are a significant medical burden for affected individuals and the healthcare system. The purpose of this investigation was to integrate the findings of two randomized studies of omadacycline (OMC) in ABSSSI. Methods OMC in Acute Skin and Skin Structure Infections Study (OASIS)-1 initiated patients on intravenous (IV) OMC or linezolid (LZD) with a possible transition to oral formulation after at least 3 days of IV therapy. OASIS-2 investigated oral-only OMC. Treatment duration in both studies was 7–14 days. Early clinical response (ECR) in the mITT population

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Sax, Paul, Keri N. Althoff, Keri N. Althoff, et al. "LB-7. Weight Change in Suppressed People with HIV (PWH) Switched from Either Tenofovir Disoproxil Fumarate (TDF) or Abacavir (ABC) to Tenofovir Alafenamide (TAF)." Open Forum Infectious Diseases 7, Supplement_1 (2020): S846—S847. http://dx.doi.org/10.1093/ofid/ofaa515.1904.

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Abstract Background Weight gain in PWH occurred in both naïve and switch studies and is linked to use of integrase inhibitors (INSTIs) with varying associations with nucleoside reverse transcriptase inhibitors (NRTIs). One hypothesis is that gain associated with TAF when switching from TDF is a result of cessation of TDF-induced weight suppression. Methods The study evaluated weight change in suppressed PWH on INSTI+NRTIs switched from ABC or TDF to TAF. Eligible pts had HIV, were ≥ 18 yrs at index (date of switch), treatment-experienced with known prior regimen, suppressed at index (-12 to +1

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Sax, Paul E., Edwin Dejesus, Gordon Crofoot, et al. "A Randomized Trial of Bictegravir or Dolutegravir with Emtricitabine and Tenofovir Alafenamide (F/TAF) Followed by Open Label Switch to Bictegravir/F/TAF Fixed Dose Combination." Open Forum Infectious Diseases 4, suppl_1 (2017): S426—S427. http://dx.doi.org/10.1093/ofid/ofx163.1076.

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Abstract Background Integrase strand transfer inhibitors (INSTIs) are widely recommended for initial HIV-1 treatment. Bictegravir (BIC, B) is a novel, once-daily INSTI with potent antiviral activity being developed in coformulation with emtricitabine and tenofovir alafenamide (F/TAF). Methods In this Phase 2 study, treatment naïve, HIV-infected adults were randomized 2:1 to receive blinded treatment with BIC or dolutegravir (DTG) coadministered with open label F/TAF (200/25 mg). After all participants completed 48 weeks, they were unblinded and switched to a single fixed-dose combination table

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Jacobs, Michael R., Caryn E. Good, Ayman M. Abdelhamed, et al. "1348. In vitro Activity of Plazomicin, a Next-Generation Aminoglycoside, Against Carbapenemase-Producing Klebsiella pneumoniae." Open Forum Infectious Diseases 5, suppl_1 (2018): S412—S413. http://dx.doi.org/10.1093/ofid/ofy210.1179.

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Abstract Background Plazomicin is a next-generation aminoglycoside with in vitro activity against multidrug-resistant Gram-negative species, including carbapenem-resistant isolates. The Consortium on Resistance Against Carbapenems in Klebsiella and other Enterobacteriaceae (CRACKLE) is a federally funded, prospective multicenter consortium of 20 hospitals from nine US healthcare systems to track carbapenem-resistant Enterobacteriaceae. Methods Minimum inhibitory concentrations (MICs) of plazomicin were determined by broth microdilution according to current CLSI guidelines against a collection

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Galaverna, Federica, Robert Wynn, Patrizia Comoli, et al. "1732. Adenovirus Load Dynamics Are Consistently Correlated With Risk of Mortality in Pediatric Allogeneic Hematopoietic Cell Transplant Recipients: Findings From the Landmark AdVance Study." Open Forum Infectious Diseases 5, suppl_1 (2018): S58—S59. http://dx.doi.org/10.1093/ofid/ofy209.138.

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Abstract Background Adenovirus (AdV) infection is an important cause of mortality among allogeneic hematopoietic cell transplant (allo-HCT) recipients. Current European Conference of Infections in Leukemia (ECIL-4) guidelines support weekly AdV screening for those at-risk and pre-emptive antiviral treatment with off-label cidofovir when adenoviremia is detected. However, there is limited understanding of the relative prognostic strength of different dynamic AdV viral load measures. We examined the association between adenovirus viral load dynamics and mortality in pediatric allo-HCT recipients

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Hüttel, Björn A., Zelal Ates, Jan Hendrik Schumann, et al. "The influence of customer characteristics on frontline employees’ customer need knowledge." Journal of Services Marketing 33, no. 2 (2019): 220–32. http://dx.doi.org/10.1108/jsm-11-2017-0367.

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PurposeThis paper aims to investigate the influence of individual customer characteristics on frontline employees’ (FLEs) customer need knowledge (CNK), a construct that objectively measures FLEs’ ability to accurately identify a given customer’s hierarchy of needs.Design/methodology/approachThe study uses hierarchical data involving the customer and bank advisor levels in the banking sector of three European countries. The matched sample consisted of 1,166 customers and 332 employees. To account for the nested structure of the data, the study used hierarchical linear modeling (HLM) using HLM

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Orkin, Chloe, Kathleen Squires, Jean-Michel Molina, et al. "LB1. Doravirine/Lamivudine/Tenofovir DF Continues to Be NonInferior to Efavirenz/Emtricitabine/Tenofovir DF in Treatment-Naïve Adults With HIV-1 Infection: Week 96 Results of the DRIVE-AHEAD Trial." Open Forum Infectious Diseases 5, suppl_1 (2018): S759. http://dx.doi.org/10.1093/ofid/ofy229.2175.

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Abstract Background Doravirine (DOR) is a novel non-nucleoside reverse-transcriptase inhibitor (NNRTI). In the phase 3 DRIVE-AHEAD trial in HIV-1-infected treatment-naïve adults, DOR demonstrated noninferior efficacy to efavirenz (EFV) and favorable profiles for neuropsychiatric tolerability and lipids at 48 weeks. We present data through week 96. Methods DRIVE- AHEAD (Clinical Trials Registration: NCT02403674) is a phase 3, multicenter, double-blind, noninferiority trial that compared DOR with EFV. Eligible participants were HIV-1-infected treatment-naïve adults with pre-treatment HIV-1 RNA ≥

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Marzuki, Diky Muhammad. "Peran Karel Frederick Holle dalam Perkembangan Pertanian dan Pendidikan di Garut." Historia Madania: Jurnal Ilmu Sejarah 3, no. 1 (2020): 27–34. http://dx.doi.org/10.15575/hm.v3i1.9393.

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This paper discusses a very important figure in the development of language and literature in the city of Garut. Karel Frederick Holle was a Dutchman who came to the Indies at the age of 14 years. He began life in the Dutch East Indies as a housing administration employee in Cianjur. Followed by becoming a Dutch government employee in Batavia and ended up being an honorary advisor for land affairs in the administration department as well as a tea and coffee plantation owner in Cikajang Garut. This paper discusses K. F. Holle in outline. The author is aware of the lack of sources used due to th

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Soriano, Alex, Laura A. Puzniak, Matteo Bassetti, et al. "1612. Evaluation of the Use of Ceftolozane/Tazobactam for the Treatment of ESBL-producing Enterobacterales Infections Using International Data from SPECTRA (Study of Prescribing Patterns and Effectiveness of Ceftolozane/Tazobactam Real World Analysis)." Open Forum Infectious Diseases 7, Supplement_1 (2020): S800. http://dx.doi.org/10.1093/ofid/ofaa439.1792.

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Abstract Background There is a paucity of data on outcomes of patients with severe ESBL-producing Enterobacterales infections treated with empiric or directed ceftolozane/tazobactam (C/T). This study looked at the treatment patterns and outcomes associated with C/T use in the treatment of ESBL-producing Enterobacterales. Methods Data were collected from an international cohort of 32 hospitals in 6 countries as part of SPECTRA, a retrospective multicenter database of C/T use globally, from 2016 – 2019. All adult patients with an ESBL positive Enterobacterales sterile site culture and treated wi

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López-Fauqued, Marta, Laura Campora, Frédérique Delannois, et al. "Results of a Safety Pooled Analysis of an Adjuvanted Herpes Zoster Subunit Vaccine in More than 14,500 Participants Aged 50 Years or Older." Open Forum Infectious Diseases 4, suppl_1 (2017): S416. http://dx.doi.org/10.1093/ofid/ofx163.1042.

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Abstract Background The recombinant herpes zoster (HZ) subunit vaccine (HZ/su) has shown efficacy against HZ in adults ≥50 and ≥70 years of age (YOA), in two pivotal Phase III clinical trials (NCT01165177, NCT01165229). A pooled safety analysis of data from these two efficacy studies was performed, including a comparative analysis on HZ/su vs. placebo groups, to provide a comprehensive understanding of the HZ/su safety profile. Methods Two pivotal, randomized, placebo-controlled Phase III studies, assessed the efficacy, reactogenicity and safety of HZ/su, administered intramuscularly according

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Patterson, Brandon J., Philip O. Buck, Justin Carrico, et al. "Assessment of the Potential Herpes Zoster and Post Herpetic Neuralgia Case Avoidance with Vaccination in the United States." Open Forum Infectious Diseases 4, suppl_1 (2017): S413. http://dx.doi.org/10.1093/ofid/ofx163.1034.

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Abstract Background Herpes zoster (HZ), commonly referred to as shingles, is a reactivation of latent varicella zoster virus in patients previously infected. Clinical characteristics of HZ include painful rash with potential complications, including post herpetic neuralgia (PHN). Care for HZ and PHN incurs significant costs and vaccination is beneficial. The aim of this study was to compare the impact on HZ and PHN case avoidance of two HZ vaccines, an available live-attenuated zoster vaccine (zoster vaccine live [ZVL]) vs. a candidate non-live adjuvanted HZ subunit vaccine (HZ/su), in the US

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Shaffelburg, Zach, Michaela Nichols, Lingyun Ye, et al. "Impact of Antivirals in the Prevention of Serious Outcomes Associated with Influenza in Hospitalized Canadian Adults: A Pooled Analysis from the Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN)." Open Forum Infectious Diseases 4, suppl_1 (2017): S18. http://dx.doi.org/10.1093/ofid/ofx162.046.

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Abstract Background Antiviral treatment of influenza in outpatient settings is associated with modest improvement in outcomes but benefit in inpatient settings remains unclear. We assessed the impact of antiviral treatment on the severe outcomes death and intensive care unit (ICU) admission and/or need for mechanical ventilation (MV) in hospitalized influenza patients. Methods Patients admitted to hospitals of the CIRN SOS Network with an acute respiratory illness from 2011/12–2013/14 who tested polymerase chain reaction (PCR) positive for influenza were included. Demographic and medical infor

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Kaye, Keith, Louis B. Rice, Viktor Stus, et al. "1367. Clinical Cure in Secondary Efficacy Populations in Patients With Complicated Urinary Tract Infection Treated With ZTI-01 (Fosfomycin for Injection): Findings From the ZEUS Trial." Open Forum Infectious Diseases 5, suppl_1 (2018): S418—S419. http://dx.doi.org/10.1093/ofid/ofy210.1198.

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Abstract Background ZTI-01 (fosfomycin for injection) is an investigational epoxide antibiotic with a differentiated mechanism of action (MOA) inhibiting an early step in bacterial cell wall synthesis. ZTI-01 has a broad spectrum of in vitro activity, including multidrug-resistant Gram-negative pathogens, and is being developed for the treatment of patients with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) in the United States. Methods ZEUS was a multicenter, double-blind, Phase 2/3 trial in hospitalized adults with cUTI and AP to evaluate safety and efficacy. Rando

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Bergin, Stephen P., Adrian Coles, Sara B. Calvert, et al. "872. PROPHETIC: Predicting Pneumonia in Hospitalized Patients in the ICU—A Model and Scoring System." Open Forum Infectious Diseases 5, suppl_1 (2018): S25. http://dx.doi.org/10.1093/ofid/ofy209.056.

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Abstract Background Prospectively identifying patients at highest risk for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) by implementing a risk assessment scoring tool may help focus prevention efforts, optimize the screening process to improve clinical trial feasibility, and enhance development of new antibacterial agents. Methods Within the intensive care units (ICU) of 28 US hospitals, between February 6, 2016 and October 7, 2016, patients hospitalized &gt;48 hours and receiving high levels of respiratory support were prospectively followed for meeting the

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Pappas, Peter, Bart Jan Kullberg, Jose A. Vazquez, et al. "147. Clinical Safety and Efficacy of Novel Antifungal, Fosmanogepix, in the Treatment of Candidemia: Results from a Phase 2 Proof of Concept Trial." Open Forum Infectious Diseases 7, Supplement_1 (2020): S203—S204. http://dx.doi.org/10.1093/ofid/ofaa439.457.

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Abstract Background Fosmanogepix (FMGX) is a first-in-class antifungal agent, with a unique MOA targeting the fungal enzyme Gwt1, that has broad-spectrum activity against both yeasts, molds, and dimorphic fungi, including fungi resistant to other antifungal agents. FMGX has a favorable safety profile, reduced potential for clinically significant drug-drug interactions, and is formulated for IV and oral administration. Methods This global, multicenter, open-label, non-comparative study evaluated the safety and efficacy of FMGX for first-line treatment of candidemia. Patients with a recent diagn

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Raval, Amit D., Kristin Kistler, Yuexin Tang, Yoshihiko Murata, and David R. Snydman. "1706. Association between Cytomegalovirus Infection/Disease and Morbidity and Mortality in Kidney Transplantation: A Systematic Literature Review of Observational Studies." Open Forum Infectious Diseases 7, Supplement_1 (2020): S835—S836. http://dx.doi.org/10.1093/ofid/ofaa439.1884.

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Abstract Background Cytomegalovirus (CMV) is a common pathogen in kidney transplant recipients (KTRs). KTRs may develop CMV viremia that is asymptomatic (‘CMV infection’) or associated with clinical and laboratory findings (‘CMV disease’) such as fever, leukopenia/neutropenia, and malaise (‘CMV syndrome’), and/or evidence of specific organ(s) involvement (‘CMV end-organ disease’). The extent to which CMV affects morbidity such as acute rejection (AR), graft loss (GL), other opportunistic infections (OI), or mortality in KTRs has not been systematically evaluated recently. Therefore, we examine

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Desai, Amit, Laura Kovanda, Christopher Lademacher, et al. "1396. Predictions of Isavuconazonium Sulfate Dosage in Patients Aged 6 Months: <18 Years by Physiologically Based Pharmacokinetic Modeling." Open Forum Infectious Diseases 5, suppl_1 (2018): S429—S430. http://dx.doi.org/10.1093/ofid/ofy210.1227.

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Abstract Background Best practice to establish dosage regimens for “first-in-pediatric” clinical trials requires knowledge of efficacious and safe exposures in adults. Methods Pediatric equivalent doses were predicted for patients aged 6 months and &lt;18 years using physiologically based pharmacokinetic (PBPK) modeling, and compared with predictions by allometric scaling. All simulations were completed using PK-Sim®, which implements a whole-body PBPK model with 15 organs and appropriate maturation of anatomical and physiological parameters for children. The adult PBPK model was built usi

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