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Academic literature on the topic 'Drug ABX'
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Journal articles on the topic "Drug ABX"
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Kim, Yoon-Myung, Mi-Sun Yum, Sun Hee Heo, et al. "Pharmacologic properties of high-dose ambroxol in four patients with Gaucher disease and myoclonic epilepsy." Journal of Medical Genetics 57, no. 2 (2019): 124–31. http://dx.doi.org/10.1136/jmedgenet-2019-106132.
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BackgroundAmbroxol (ABX) has been suggested as an augmentative pharmacological agent for neuronopathic Gaucher disease (nGD). This study assessed the long-term safety and efficacy of combined therapy with high-dose ABX and enzyme replacement therapy (ERT) in nGD.MethodsABX+ERT therapy was administered for 4.5 years in four patients with nGD. ABX was initiated at a dose of 1.5 mg/kg/day, and the dose was escalated up to 27 mg/kg/day. The target plasma level was 10 µmol/L or less. The changes in glucocerebrosidase activity, biochemical, safety and neurocognitive findings were assessed.ResultsEnhanced residual GCcase activity was observed in all patients, as evidenced in both in vitro and in vivo studies. During the first 2 years of study with ABX (up to 21 mg/kg/day), mean seizure frequencies and neurocognitive function worsened. After ABX dosage was increased up to 27 mg/kg/day of ABX, its trough plasma concentration was 3.2–8.8 µmol/L. Drug-to-drug interaction, especially with antiepileptic drug significantly affected the pharmacokinetic parameters of ABX. Importantly, at 27 mg/kg/day of ABX, the seizure frequencies markedly decreased from the baseline, and the neurocognitive function was improved. In addition, Lyso-Gb1, a biomarker for the severity and progression of GD, was normalised in all patients. High-dose ABX was well-tolerated with no severe adverse events.ConclusionsLong-term treatment with high-dose ABX+ERT was safe and might help to arrest the progression of the neurological manifestations in GD.
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Medler, Corey J., Lejla Jakupovic, Allison J. Weinmann, Rachel Kenney, Susan L. Davis, and Susan L. Davis. "391. Outcomes of Empiric Antimicrobial Therapy in COVID-19 Positive Patients." Open Forum Infectious Diseases 7, Supplement_1 (2020): S264—S265. http://dx.doi.org/10.1093/ofid/ofaa439.586.
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Abstract Background The COVID-19 pandemic has revealed new challenges for antimicrobial stewardship. Optimal medical treatment is not completely understood at this time. The epidemiology and outcomes of bacterial co-infections are not well-established; however, empiric antibiotic (abx) use is anecdotally common. The purpose of this study is to characterize empiric antimicrobial drug selection and timing in COVID-19 and evaluate the impact on patient outcomes. Methods Cross-sectional cohort study for COVID-19 positive inpatients from March 1, 2020 to June 1, 2020 at an academic medical center and 4 community hospitals. Inclusion: patients with a documented positive COVID-19 PCR nasopharyngeal swab. Exclusion: patients less than 18 years; deceased or transitioned to hospice within 24 hours of admission. Primary endpoint: empiric abx drug, initiation, duration and indication. Additional data collected: severity of illness, co-infection diagnosis, microbiology, and adverse drug effects (ADE). Clinical outcomes included time to recovery by COVID-19 ordinal outcome, clinical status at day 15, and readmission. Results 400 patients were included with 27% from the ICU. COVID symptom category included mild (23.8%), moderate (53%), severe (15%), and critical (8.3%). 322 (80.5%) received abx at any time during hospital stay, 301 (93.5%) started within 1 day of admission. Most common documented indication community-acquired pneumonia (69%). Identified 43 (10.8%) microbiologically confirmed co-infections, including 5 MRSA and 7 Pseudomonas. Median duration of initial abx 4 days. 54/322 (16.8%) had abx restarted after discontinuation. Median days to recovery without abx was 10 days (7 – 14) and 14 days (9 – 20) with abx. Patient characteristics and outcomes described in table 1. 74 abx related ADE were identified: gastrointestinal 37 and renal 22. Conclusion It’s difficult to distinguish bacterial and Covid-19 in coinfections in patients ill enough to be hospitalized. Longer courses of empiric abx therapy were prevalent as the severity of illness increased. However, the low frequency of microbiologically confirmed bacterial co-infections results in potentially unnecessary abx exposure. This exposure increases risk of abx ADE and may not improve clinical outcome. Disclosures All Authors: No reported disclosures
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Shah, Ruta M., Zbigniew M. Szczepiorkowski, Miriam K. Leach, MS, MT, and Richard A. Zuckerman. "The Significance of Anti-Platelet Antibodies Associated with Antibiotic Use, A Descriptive Analysis." Blood 114, no. 22 (2009): 4470. http://dx.doi.org/10.1182/blood.v114.22.4470.4470.
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Abstract Abstract 4470 Introduction Antibiotics (Abx) have been implicated in immune thrombocytopenia via drug dependent platelet antibodies (DDPA). Our institution has had a DDPA assay available since 1994 which is used to guide clinical decisions. We performed a retrospective review to determine the significance of DDPA. Methods We reviewed the medical records of patients (pts) who tested positive for abx DDPA between 1994 and 2006 and performed a descriptive analysis. Detection of DDPAs was performed using a previously described, modified solid phase red cell adherence assay that detects hapten or immune complex reactions. Results A total of 71 pts were included in this analysis. Multiple classes of abx were tested. Platelet nadir was <50 in 70%, between 50 and 100 in 26% and over 100 in 4% of pts. Pts had between 1 and 4 abx tested: 37% had 1, 37% had 2, 15% had 3, and 11% had 4 tested; 65% of pts had one abx positive and 35% had >1 abx positive for DDPA. Of those with >1 abx tested (n=45), 14 (31%) had all tested abx positive. 53% of abx testing took place on or after the abx stop date and 32% of abx tested were administered for <=3 days. Only 29 of 38 pts receiving heparin were tested for heparin-associated antibodies, and 14 had positive results. 49 pts had other non-abx drugs tested, 19 with positive DDPA. Thus, 35% had alternative non-abx testing positive for DDPA. 31% of pts had bleeding complications and 35% of pts died during hospitalization. Excluding pts who died and those with non-abx positive DDPA left 25 pts, median platelet counts were: abx start=142; nadir=22, abx discontinuation=46, hospital discharge=192. Conclusions Antibiotic DDPA testing is usually performed in ill pts with multiple medical complications and comorbidities. Abx were stopped for concern of DDPA in a number of pts for whom typical immune thrombocytopenia was not present or alternative explanations could be found. Though some pts exhibited improvement in platelet count after abx were stopped, a clear understanding of which pts may benefit from DDPA testing could not be determined based on the retrospective nature of this study and the complexity of pts histories. Further research is necessary to clarify the clinical applicability of DPPA testing. Disclosures: Szczepiorkowski: Cersus Corporation: Research Funding; CaridianBCT: Research Funding; BASF: Research Funding; Terumo Corporation: Research Funding; Fenwel, Inc - Scientific Advisory Board: Research Funding.
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Weinstock, Chana, Pradeep Bandaru, Laura L. Fernandes, et al. "Impact of timing of antibiotic use on clinical outcomes in patients with urothelial cancer treated with immune checkpoint inhibitors (ICIs)." Journal of Clinical Oncology 38, no. 15_suppl (2020): 5045. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.5045.
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5045 Background: Although recent evidence has suggested that patients who receive antibiotics (ABX) during the course of ICI treatment might decrease overall survival (OS) (1), our previous analysis did not support a difference in OS in urothelial cancer patients who did and did not use ABX during the course of ICI treatment without regard to timing (2). This updated analysis aims to addresses the question of timing; specifically, use of ABX in the 30-day window pre- or post- initiation of ICI treatment. Methods: We pooled data from 7 trials that led to drug approval and which included 1747 patients with advanced urothelial cancer treated with an ICI. Five trials enrolled patients who received prior platinum and 2 enrolled cisplatin-ineligible patients. Concomitant medication datasets were searched for systemic ABX use. The association between ABX use and survival was evaluated using Kaplan-Meier estimates and Cox proportional hazards regression models stratified by study. Results: Overall, 56% of patients were exposed to antibiotics (ABX+) and 43% were not exposed (ABX-). In an exploratory analysis, median OS was similar between arms: 9.7 vs. 9.3 months in ABX+ vs. ABX- patients, respectively (HR 0.96). However, OS results differed in the 27% of patients who were exposed to antibiotics in the 30-day window pre- or post- initiation of ICI treatment, for whom median OS was 4.7 months vs. 11.5 months in the ABX+ vs. ABX- patients, respectively (HR 1.8). This remained true after controlling for baseline risk prognostic factors (Bajorin and Bellmunt scores). Similar trends were observed for progression-free survival (PFS). Conclusions: Patients treated with ABX while on therapy with an ICI for urothelial cancer had similar OS outcomes to those not treated with ABX. However, in an exploratory analysis looking at ABX use in the 30-day window pre- or post-initiation of ICI treatment, OS appeared decreased in ABX+ vs ABX- patients. Our exploratory analyses appear to show an association of OS/PFS with timing of antibiotics. References: 1) Routy B, Science (2017) 2) Weinstock C, ASCO 2019, abstract. [Table: see text]
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Park, Jenny, Mohamed Nakeshbandi, Subodh Saggi, and Roopali Sharma. "1084. A Pre- and Post-Intervention Study to Implement a Successful Antimicrobial Stewardship Program at an Urban Chronic Hemodialysis Center." Open Forum Infectious Diseases 6, Supplement_2 (2019): S385. http://dx.doi.org/10.1093/ofid/ofz360.948.
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Abstract Background Patients receiving chronic outpatient hemodialysis (CHD) are at high risk for bloodstream and vascular access infections due to the immune-compromised status of patients and repeated vascular access. CHD patients are especially vulnerable to multidrug-resistant organisms due to extensive exposure to antibiotics (ABX). It is estimated that more than 40% of CHD patients receive ≥1 ABX course each year. As data characterizing ABX use and reasons for inappropriate prescribing is still scarce in CHD patients, our objective was to assess ABX use pre- and post-implementation of antimicrobial stewardship program (ASP). Methods A retrospective cohort study to analyze appropriate ABX use from 2015–2018 in CHD patients was conducted. Starting January 15, 2019, ASP was established at the hemodialysis center and tracked all ABX doses including appropriate indication, dosage, frequency, route, therapeutic drug monitoring (TDM) and duration of therapy. All results are presented as descriptive statistics. Results Of the 250 accounts of antibiotics that were assessed retrospectively in all patients from ages 12 to 95 years old, 50% of antibiotics ordered were inappropriately prescribed. The following were the reasons for inappropriateness: indication (59%), duration (14%), culture susceptibility (7%), dose (12%), narrow-spectrum warranted (2%), TDM (6%). Twenty-three accounts were assessed post-implementation phase. ASP implementation led to 100% compliance with regards to the appropriateness of ABX usage (indication, dose, and duration). Additional, ASP interventions included recommendations to obtain blood cultures and conduct TDM in 47% of patients. Conclusion This study identified inappropriateness of antibiotic usage without an established ASP in CHD patients. Implementation of ASP was associated with a positive impact on all ABX doses prescribed and this can have a significant outcome on optimizing ABX use in CHD patients. Disclosures All authors: No reported disclosures.
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Rowinsky, Eric K., Garry H. Schwartz, Jared A. Gollob, et al. "Safety, Pharmacokinetics, and Activity of ABX-EGF, a Fully Human Anti–Epidermal Growth Factor Receptor Monoclonal Antibody in Patients With Metastatic Renal Cell Cancer." Journal of Clinical Oncology 22, no. 15 (2004): 3003–15. http://dx.doi.org/10.1200/jco.2004.11.061.
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Purpose To determine the antitumor activity of ABX-EGF, a fully human monoclonal antibody to the epidermal growth factor receptor (EGFr), in previously treated patients with metastatic renal cell carcinoma, and to characterize its toxicity, immunogenicity, pharmacokinetics, and pharmacodynamics. Patients and Methods The antitumor activity, as well as the toxicity, pharmacokinetics, pharmacodynamics, and immunogenicity of ABX-EGF, were assessed. Results Eighty-eight patients were treated with ABX-EGF doses of 1.0, 1.5, 2.0, or 2.5 mg/kg weekly with no loading dose. EGFr immunostaining was performed on 76 tumor biopsy specimens (86%), and 69 (91%) scored positive. Major responses occurred in three patients, and two patients had minor responses. Forty-four patients (50%) also had stable disease at their first 8-week assessment, and the median progression-free survival (PFS) was 100 days (95% CI, 58 to 140 days). Low hemoglobin and high alkaline phosphatase predicted for short PFS. The principal toxicity, an acneiform rash, occurred in 68%, 95%, 87%, and 100% of patients who received at least three doses of ABX-EGF at 1.0, 1.5, 2.0, and 2.5 mg/kg/wk, respectively. A trend indicated that the severity of the rash may relate to PFS. No human antihuman antibodies were detected. ABX-EGF pharmacokinetics fit a model that incorporated both linear and saturable EGFr-mediated clearance mechanisms, and interindividual variability was low. At 2.5 mg/kg/wk, ABX-EGF concentrations throughout treatment exceeded those estimated to saturate nonlinear clearance and inhibit xenograft growth by 90%. Conclusion ABX-EGF was generally well tolerated. The objective response rate was low in previously treated patients with metastatic renal cell carcinoma. Although skin rash may be a pharmacodynamic marker of drug action, its potential as a surrogate marker of clinical benefit requires further evaluation.
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Yin, Xin, Nkuchia M. M’ikanatha, Lisa Dettinger, et al. "623. Antimicrobial Resistance in Non-Typhoidal Salmonella from Retail Poultry Meat by Antibiotic Usage-related Production Claims—Pennsylvania, 2008–2017." Open Forum Infectious Diseases 6, Supplement_2 (2019): S289. http://dx.doi.org/10.1093/ofid/ofz360.691.
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Abstract Background Antimicrobial-resistant (AMR) nontyphoidal Salmonella infections are a public health concern. Injudicious use of antimicrobials fuels emergence of resistance. The National Antimicrobial Resistance Monitoring System (NARMS) tracks AMR in Salmonella from humans, animals and foods. There is limited evidence regarding antimicrobial use in food animals and AMR bacteria in retail meat. Methods We reviewed antimicrobial susceptibility and whole-genome sequencing data from 320 Salmonella isolated from poultry meat in Pennsylvania as part of NARMS activities. Salmonella strains were isolated from 3,481 samples purchased from randomly selected retail outlets during 2008–2017. Antibiotic usage claims on meat packages were used to compare AMR Salmonella from conventional and antibiotic-free/organic (Abx-free) samples. Genetic mechanisms for AMR were investigated in a subset of isolates. Results The prevalence of Salmonella in conventional poultry meat 10.2% (280/2,733) was significantly higher than the prevalence in poultry meat labeled as Abx-free (5.3%, 40/748; P < 0.0001). Salmonella from conventional poultry meat was more likely to be resistant to 3 or more drugs (55.0%, 154/280) compared with poultry meat labeled as Abx-free (27.5%, 11/40; P = 0.0011). Salmonella from conventional poultry exhibited significantly higher resistance to 4 drug classes including β-lactams (P = 0.006) (figure). One hundred isolates from conventional poultry meat and 8 isolates from antibiotic-free/organic samples harbored a gene conferring resistance to the β-lactam class; 24.3% (68/280) of isolates from conventional and 7.5% (3/40) of isolates from Abx-free samples (P = 0.0145) contained the extended-spectrum β-lactamase (ESBL) gene blaCMY-2. Conclusion Meat samples from conventionally-raised poultry were more likely to be contaminated with AMR Salmonella strains and have genes that reduce the effectiveness of antimicrobial drugs recommended for treatment of severe infections. Contamination of poultry with AMR Salmonella strains is concerning as is the presence of genes that decrease the power of critical antibiotics such as β-lactams. These findings highlight the importance of judicious use of antibiotics in food-producing animals. Disclosures All authors: No reported disclosures.
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Weinstock, Chana, Virginia Ellen Maher, Laura L. Fernandes, et al. "Impact of antibiotic use on clinical outcomes in patients with urothelial cancer receiving a programmed death protein 1 or programmed death ligand 1 (anti-PD-1/L1) antibody." Journal of Clinical Oncology 37, no. 15_suppl (2019): 4557. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.4557.
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4557 Background: Previous data has suggested that patients treated with anti-PD-1/L1 antibodies who receive antibiotics during their therapy might have dramatically decreased progression-free and overall survival 1,2. This has clinical implications for management of patients with suspected bacterial infection while on treatment with these agents. We assessed the relationship between antibiotic use and tumor response rate, progression-free survival, and overall survival in a large dataset of patients with urothelial cancer treated with anti-PD-1/L1 antibodies. Methods: We examined seven trials that led to drug approval and which included 1747 patients with metastatic or locally advanced urothelial cancer treated with an anti-PD-1/L1 antibody. Five trials enrolled patients who had received prior platinum-based therapy and two enrolled patients who were cisplatin-ineligible. Six were single arm trials and one was a randomized controlled trial whose control arm is not included in these analyses. Concomitant medication datasets were searched for systemic antibiotic used by each patient while on treatment. Results: Overall, 51% of patients (n=892) were exposed to antibiotics (ABX+) and 49% (n=855) were not exposed (ABX-). In these exploratory analyses, small numeric differences in OS, PFS, and ORR were seen in ABX+ vs. ABX- patients. Median OS was 9.23 vs. 9.86 months, median PFS was 105 vs 101 days, and ORR was 20% vs. 21% in ABX+ vs. ABX- patients, respectively. Conclusions: Patients who were treated with antibiotics while on therapy with an anti-PD-1/L1 antibody for urothelial cancer had similar outcomes to those who were not treated with antibiotics. Numeric differences in outcomes were not significant and did not duplicate previous analysis demonstrating a median OS that was doubled in ABX- patients1. Our exploratory analyses do not appear to demonstrate a clear need for practitioners to avoid antibiotic use in patients treated with PD-1/L1 agents for fear of significantly impacting clinical outcomes. References: 1) Tinsley et. al., ASCO annual meeting 2018, abstract 3010 2) Routy et. al., Science 05 Jan 2018: Vol. 359, Issue 6371. [Table: see text]
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Geum, Min Jung, Chungsoo Kim, Ji Eun Kang, et al. "Broad-Spectrum Antibiotic Regimen Affects Survival in Patients Receiving Nivolumab for Non-Small Cell Lung Cancer." Pharmaceuticals 14, no. 5 (2021): 445. http://dx.doi.org/10.3390/ph14050445.
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Antibiotic-induced dysbiosis may affect the efficacy of immune checkpoint inhibitors. We investigated the impact of antibiotics on the clinical outcomes of nivolumab in patients with non-small cell lung cancer (NSCLC). Patients who received nivolumab for NSCLC between July 2015 and June 2018 and who were followed up until June 2020 were included in a retrospective cohort analysis. Of 140 eligible patients, 70 were on antibiotics. Overall survival (OS) was shorter in patients on antibiotics (ABX) compared to those not on antibiotics (NoABX) (p = 0.014). OS was negatively associated with piperacillin/tazobactam (PTZ) (HR = 3.31, 95% CI: 1.77–6.18), days of therapy (DOT) ≥ 2 weeks (HR = 2.56, 95% CI: 1.30–5.22) and DOT of PTZ. The defined daily dose (DDD) in PTZ (r = 0.27) and glycopeptides (r = 0.21) showed weak correlations with mortality. There was no difference in progression-free survival (PFS) between ABX and NoABX; however, PFS was negatively associated with the antibiotic class PTZ and DOT of PTZ. Therefore, the use of a broad-spectrum antibiotic, such as PTZ, the long-term use of antibiotics more than 2 weeks in total and the large amount of defined daily dose of specific antibiotics were associated with decreased survival in patients receiving nivolumab for NSCLC.
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Wang, Elaine E. L., Thomas Einarson, James D. Kellner, and John Conly. "Antibiotic (ABX) Prescribing for Respiratory Tact Infections in Preschool Children: Analysis of the Saskatchewan Drug Database † 550." Pediatric Research 43 (April 1998): 96. http://dx.doi.org/10.1203/00006450-199804001-00571.
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