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1

Sutter, Raoul, Stephan Rüegg, and Sarah Tschudin-Sutter. "Seizures as adverse events of antibiotic drugs." Neurology 85, no. 15 (September 23, 2015): 1332–41. http://dx.doi.org/10.1212/wnl.0000000000002023.

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Tribble, Alison C. "Antibiotic-treated otitis media and adverse events." Journal of Pediatrics 222 (July 2020): 253–57. http://dx.doi.org/10.1016/j.jpeds.2020.04.025.

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Meropol, Sharon B., K. Arnold Chan, Zhen Chen, Jonathan A. Finkelstein, Sean Hennessy, Ebbing Lautenbach, Richard Platt, Stephanie D. Schech, Deborah Shatin, and Joshua P. Metlay. "Adverse events associated with prolonged antibiotic use." Pharmacoepidemiology and Drug Safety 17, no. 5 (2008): 523–32. http://dx.doi.org/10.1002/pds.1547.

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Lovegrove, Maribeth C., Andrew I. Geller, Katherine E. Fleming-Dutra, Nadine Shehab, Mathew R. P. Sapiano, and Daniel S. Budnitz. "US Emergency Department Visits for Adverse Drug Events From Antibiotics in Children, 2011–2015." Journal of the Pediatric Infectious Diseases Society 8, no. 5 (August 23, 2018): 384–91. http://dx.doi.org/10.1093/jpids/piy066.

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Abstract Background Antibiotics are among the most commonly prescribed medications for children; however, at least one-third of pediatric antibiotic prescriptions are unnecessary. National data on short-term antibiotic-related harms could inform efforts to reduce overprescribing and to supplement interventions that focus on the long-term benefits of reducing antibiotic resistance. Methods Frequencies and rates of emergency department (ED) visits for antibiotic adverse drug events (ADEs) in children were estimated using adverse event data from the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project and retail pharmacy dispensing data from QuintilesIMS (2011–2015). Results On the basis of 6542 surveillance cases, an estimated 69464 ED visits (95% confidence interval, 53488–85441) were made annually for antibiotic ADEs among children aged ≤19 years from 2011 to 2015, which accounts for 46.2% of ED visits for ADEs that results from systemic medication. Two-fifths (40.7%) of ED visits for antibiotic ADEs involved a child aged ≤2 years, and 86.1% involved an allergic reaction. Amoxicillin was the most commonly implicated antibiotic among children aged ≤9 years. When we accounted for dispensed prescriptions, the rates of ED visits for antibiotic ADEs declined with increasing age for all antibiotics except sulfamethoxazole-trimethoprim. Amoxicillin had the highest rate of ED visits for antibiotic ADEs among children aged ≤2 years, whereas sulfamethoxazole-trimethoprim resulted in the highest rate among children aged 10 to 19 years (29.9 and 24.2 ED visits per 10000 dispensed prescriptions, respectively). Conclusions Antibiotic ADEs lead to many ED visits, particularly among young children. Communicating the risks of antibiotic ADEs could help reduce unnecessary prescribing. Prevention efforts could target pediatric patients who are at the greatest risk of harm.
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Gautam, Sandesh, Rajeev Shrestha, Mohammad R. Ghani, Mahmoud M. Ali, Manish KC, Yomna A. Elfert, Vanessa Chong, and Bayode Romeo Adegbite. "Efficacy and safety of different therapies of non-steroidal anti-inflammatory drugs against antibiotic monotherapy in the treatment of uncomplicated lower urinary tract infection: A systematic review." SAGE Open Medicine 10 (January 2022): 205031212211223. http://dx.doi.org/10.1177/20503121221122392.

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This systematic review aimed to evaluate the efficacy of different non-steroidal anti-inflammatory drugs therapy (monotherapy or combined with antibiotics) against antibiotics monotherapy to understand the possible role of non-steroidal anti-inflammatory drugs in managing uncomplicated urinary tract infections and reduce overall antibiotic prescription. We searched four databases: PubMed, EMBASE, Scopus, and Cochrane CENTRAL. We included randomized controlled trials, which had included non-pregnant females above 18 years, published from 2010 to 2020 AD in the English language. We assessed risk of bias (ROB) using COCHRANE ROB version 2.0. We synthesized the conclusion from low ROB studies. Among five included studies, four studies compared non-steroidal anti-inflammatory drugs monotherapy against antibiotics monotherapy, and one study compared non-steroidal anti-inflammatory drugs + antibiotic therapy against antibiotic monotherapy. All studies with low ROB showed significantly higher events of symptom resolution by day 7 with antibiotic monotherapy compared to non-steroidal anti-inflammatory drugs monotherapy. Overall, adverse events were not significantly different in two of three low risk of bias studies; however, one study reported significantly higher adverse effects with non-steroidal anti-inflammatory drugs. Non-urinary tract infection–related adverse events were more common than urinary tract infections–related adverse events in both non-steroidal anti-inflammatory drugs and antibiotic groups. Urinary tract infection–related adverse events were higher in the non-steroidal anti-inflammatory drugs group compared to antibiotics. For every 20–60 participants treated, one would develop pyelonephritis additionally in non-steroidal anti-inflammatory drugs compared to antibiotics. Antibiotics were superior to non-steroidal anti-inflammatory drugs for treating uncomplicated lower urinary tract infections. However, further studies regarding the characteristics of patients likely to develop pyelonephritis on non-steroidal anti-inflammatory drugs monotherapy, and the effectiveness and safety of a combination of non-steroidal anti-inflammatory drugs and antibiotics therapy are essential to reduce the burden of antibiotics and their associated problems.
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Shah, Neel B., Beverly L. Hersh, Alex Kreger, Aatif Sayeed, Andrew G. Bullock, Scott D. Rothenberger, Brian Klatt, Brian Hamlin, and Kenneth L. Urish. "Benefits and Adverse Events Associated With Extended Antibiotic Use in Total Knee Arthroplasty Periprosthetic Joint Infection." Clinical Infectious Diseases 70, no. 4 (April 4, 2019): 559–65. http://dx.doi.org/10.1093/cid/ciz261.

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Abstract Background Total knee arthroplasty (TKA) periprosthetic joint infection (PJI) can be managed with debridement, antibiotic therapy, and implant retention (DAIR). Oral antibiotics can be used after DAIR for an extended time period to improve outcomes. The objective of this study was to compare DAIR failure rates and adverse events between an initial course of intravenous antibiotic therapy and the addition of extended treatment with oral antibiotics. Methods A multicenter observational study of patients diagnosed with a TKA PJI who underwent DAIR was performed. The primary outcome of interest was the failure rate derived from the survival time between the DAIR procedure and future treatment failure. Results One hundred eight patients met inclusion criteria; 47% (n = 51) received an extended course of oral antibiotics. These patients had a statistically significant lower failure rate compared to those who received only intravenous antibiotics (hazard ratio, 2.47; P = .009). Multivariable analysis demonstrated that extended antibiotics independently predicted treatment success, controlling for other variables. There was no significant difference in failure rates between an extended course of oral antibiotics less or more than 12 months (P = .23). No significant difference in the rates of adverse events was observed between patients who received an initial course of antibiotics alone and those who received a combination of initial and extended antibiotic therapy (P = .59). Conclusions Extending therapy with oral antibiotics had superior infection-free survival for TKA PJI managed with DAIR. There was no increase in adverse events, demonstrating safety. After 1 year, there appears to be no significant benefit associated with continued antibiotic therapy.
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Shehab, Nadine, Priti R. Patel, Arjun Srinivasan, and Daniel S. Budnitz. "Emergency Department Visits for Antibiotic‐Associated Adverse Events." Clinical Infectious Diseases 47, no. 6 (September 15, 2008): 735–43. http://dx.doi.org/10.1086/591126.

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Principi, Nicola, and Susanna Esposito. "Antibiotic-related adverse events in paediatrics: unique characteristics." Expert Opinion on Drug Safety 18, no. 9 (July 15, 2019): 795–802. http://dx.doi.org/10.1080/14740338.2019.1640678.

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Güzeloğlu, Eren, and Mehmet Karacı. "Antibiotic-associated Adverse Drug Events in Hospitalized Children." Journal of Pediatric Infection 16, no. 3 (September 23, 2022): 198–204. http://dx.doi.org/10.5578/ced.20229714.

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Mulligan, Patrick, Nirav Shah, Mary Acree, Jennfer Grant, Urmila Ravichandran, and Nader Ismail. "Adherence to Antibiotic Stewardship Program Associated with Shorter Course of Treatment and Fewer Adverse Events." Antimicrobial Stewardship & Healthcare Epidemiology 1, S1 (July 2021): s30—s31. http://dx.doi.org/10.1017/ash.2021.55.

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Group Name: NorthShore University HealthSystemBackground: Prolonged antibiotic use has been attributed to an increased incidence of adverse drug events (ADEs). Cessation of unnecessary antibiotics would decrease length of treatment and may help prevent these adverse events. We evaluated whether an antibiotic stewardship intervention aimed at stopping unnecessary antibiotic usage would both shorten the duration of treatment and reduce ADEs. Methods: At NorthShore University HealthSystem, a 4-hospital, 832-bed system, we identified patients who were started on empiric antibiotics during a hospital admission between May 2, 2016, and June 30, 2018. Within 24 hours of antibiotic initiation, an infectious disease (ID) physician reviewed each patient chart. If the patient was unlikely to have a symptomatic bacterial infection, the ID physician left a note in the electronic medical record (EMR) recommending antibiotic cessation. Two physician reviewers retrospectively reviewed whether the treatment team accepted these recommendations and assessed potential ADEs for 30 days after the recommendation through inpatient and outpatient notes in the EMR. These ADEs were defined using previously published criteria. If the 2 reviewers disagreed on the presence of an ADE, an ID physician acted as the tie breaker. We compared the number of antibiotic days and the number of ADEs between cases in which the recommendations were followed and cases in which they were not. Results: We reviewed 168 cases: 78 (46.43%) followed recommendations and 90 (53.57%) did not. There were no significant differences in baseline patient characteristics between the 2 groups. There was a significant difference in total ADEs between the 2 groups: in 6 cases (7.69%) the recommendations were followed, and 21 (23.33%) they were not followed (P = .011). There was also a significant difference in antibiotic days between cases in which recommendations were followed (1.40 days) versus those in which they were not followed (1.99 days) (p < 0.001). Conclusions: Antibiotic-associated adverse events can cause harm to patients and increase healthcare costs, particularly when used for patients who are unlikely to have a bacterial infection. An antibiotic stewardship program to identify patients in an EMR who are unlikely to benefit from antibiotic use can decrease the length of total antibiotic usage and help prevent adverse events.Funding: NoDisclosures: None
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Wilson, Brigid, Taissa A. Bej, Richard Banks, Janet Briggs, Sunah Song, Robin Jump, Robin Jump, and Federico Perez. "235. In outpatient clinics serving Veterans, antibiotic prescriptions precede a minority of antibiotic-associated adverse events." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S118. http://dx.doi.org/10.1093/ofid/ofaa439.279.

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Abstract Background An estimated 30% of antibiotic prescriptions in outpatient settings may be inappropriate. Antibiotic exposure increases an individual’s risk of Clostridioides difficile infection (CDI) and acquiring drug-resistant pathogens. To quantify the increased risk of CDI and drug-resistant pathogens posed by antibiotics prescribed in outpatient visits, we examined a two-year cohort of patients seen in primary care clinics at VA Community-Based Outpatient Clinics (CBOC) associated with a large VA Medical Center. Methods Among patients with an in-person visit at 13 CBOCs in 2018–2019, we examined rates of antibiotic-associated adverse events (AEs), defined as community-onset CDI or acquisition of resistant Gram-negative bacteria (R-GNB), in the 90 days following those visits. For each visit, we used administrative databases to determine if systemic antibiotics were prescribed, if there was an associated infectious diagnosis, and the subsequent occurrence of AEs. We summarized quarterly rates of prescribed antibiotics and AEs, characterized patients with and without AEs, and estimated the risk ratio of AE for an antibiotic prescription. Results Following 236,665 primary care visits, we observed 62 and 225 AEs due to CDI and R-GNB, respectively (0.12% combined rate) among 278 patients (5 with both). Patients who developed CDI or R-GNB had a higher Charlson Comorbidity Index (3.6 ± SD 3.0 and 2.68 ± SD 2.7, respectively) compared to those without AEs (0.72 ± SD 1.3; Table). The rate of new antibiotic prescriptions was 4% in visits without and 10% in visits with a subsequent AE, yielding a risk ratio of 2.5 (95% CI: 1.7–3.7). The rates of both antibiotic prescribing and AE were steady over the examined two-year period (Figure). Table Figure Conclusion Among all patients with a CBOC visit between 2018–2019, an AE, defined as CDI or R-GNB acquisition, was observed following only 0.1% of primary care visits. Among patients who experienced an AE, only 10% of primary care visits preceding those events included a new antibiotic prescription. While this analysis does not address antibiotics during inpatient stays or prescribed by specialty clinics, these findings suggest that among Veterans, outpatient antibiotic exposure may have only a modest contribution to the risk of AE. Disclosures Robin Jump, MD, PhD, Accelerate (Grant/Research Support)Merck (Grant/Research Support)Pfizer (Grant/Research Support, Advisor or Review Panel member)Roche (Advisor or Review Panel member) Federico Perez, MD, MS, Accelerate (Research Grant or Support)Merck (Research Grant or Support)Pfizer (Research Grant or Support)
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Chevretton, Elfy B., R. D. R. McRae, and J. B. Booth. "Mastoidectomy packs: Xeroform® or BIPP?" Journal of Laryngology & Otology 105, no. 11 (November 1991): 916–17. http://dx.doi.org/10.1017/s0022215100117803.

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AbstractA retrospective study comparing adverse events usin bismuth iodform paraffin paste (BIPP) and Xeroform as dressings for newly fashioned mastoid cavities after mastoidectomy was undertaken. There were 20 patients in each group. Adverse events were defined as offensive packs, mastoid caivity infection and systemic signs of infection. There were no adverse using BIPP packs Whether or not prophylactic antibiotics were used. Xeroform packs were associated with a significantly higher incidence of adverse events compared to BIPP when using on antibiotic porphylaxis (P<0.005) or amoxycillin (P<0.005). Adverse events with Xeroform packs were abolished using ciprofloxacin and metronidazole prophylaxis. We conclude that BIPP is the mastoid dressing of choice.
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La Regina, Davide, Francesco Mongelli, Alberto Fasoli, Gianluca Lollo, Marcello Ceppi, Andrea Saporito, Fabio Garofalo, Matteo Di Giuseppe, and Antonjacopo Ferrario di Tor Vajana. "Clinical Adverse Events after Endoscopic Resection for Colorectal Lesions: A Meta-Analysis on the Antibiotic Prophylaxis." Digestive Diseases 38, no. 1 (August 13, 2019): 15–22. http://dx.doi.org/10.1159/000502055.

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Background: Post-polypectomy coagulation syndrome (PECS) is a well-known adverse event after endoscopic polypectomy for colorectal lesions. To date, there are no standardized guidelines for the antimicrobial prophylaxis. The aim of this meta-analysis is to evaluate the usefulness of antibiotics in patients undergoing endoscopic mucosal or submucosal resections. Methods: A comprehensive literature search of PubMed, MEDLINE, EMBASE, and Web of Science databases was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies investigating the role of prophylactic antibiotic administration in reducing the PECS after endoscopic polypectomy were considered. The terms used to search were (“antimicrobial”OR”antibiotics”OR”prophylaxis”OR”prophylactic”) AND (“resection”OR”polypectomy”OR”dissection”) AND (“endoscopic”OR”mucosal”OR”submucosal”) AND (“colon”OR”colorectal”OR”colonic”OR”rectum”). Data of included studies were collected and analysed. Results: The literature search revealed 262 articles, 3 of whom were randomized trials and one was a retrospective study. Patients included were 850 (548 treated with antibiotics and 302 received no treatment). The overall incidence rate was 2.4 and 19.9% in treatment and control groups, respectively. The pooled analysis showed a reduction of 83% of postoperative events in the antibiotics group (relative risk 0.181; 95% CI 0.100–0.326, p < 0.001). Conclusions: In our meta-analysis, the antibiotic prophylaxis showed a positive effect in reducing the incidence of postoperative adverse events other than perforation and bleeding in patients treated with endoscopic mucosal resection and endoscopic submucosal dissection for colorectal lesions. Despite the low-level of evidence of this meta-analysis, the antibiotic prophylaxis should be taken into account. Further multicenter, large-sample, randomized controlled studies are needed to confirm our results and to evaluate whether specific subgroups of patients could actually benefit from an antibiotic prophylaxis.
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Liu, Jiajun, Keith S. Kaye, Nicholas J. Mercuro, Susan L. Davis, Twisha S. Patel, Lindsay A. Petty, Gwendolyn M. Pais, and Marc H. Scheetz. "It is time to define antimicrobial never events." Infection Control & Hospital Epidemiology 40, no. 2 (December 5, 2018): 206–7. http://dx.doi.org/10.1017/ice.2018.313.

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AbstractInappropriate antibiotic use is associated with increased antimicrobial resistance and adverse events that can lead to further downstream patient harm. Preventative strategies must be employed to improve antibiotic use while reducing avoidable harm. We use the term “antibiotic never events” to globally recognize and define the most inappropriate antibiotic use.
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Gosling, Mark James, and Fernando Martínez-Taboada. "Adverse reactions to two intravenous antibiotics (Augmentin and Zinacef) used for surgical prophylaxis in dogs." Veterinary Record 182, no. 3 (October 19, 2017): 80. http://dx.doi.org/10.1136/vr.104496.

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Antibiotic prophylaxis in dogs undergoing surgical procedures frequently involves the administration of a product without a veterinary licence. Two drugs commonly used for this purpose are the clavulanate amoxicillin Augmentin and the cefuroxime Zinacef. This prospective observational study aims to compare the incidence of adverse events associated with these two antibiotics in a clinical setting. The authors hypothesised that a higher incidence of adverse effects would be observed with Augmentin. Sixty-five dogs were included in the study and adverse events were recorded using a modified scoring system. A significantly higher incidence of adverse events to Augmentin (8/22; 36 per cent) was observed compared with Zinacef (1/43; 2 per cent) (P=0.0003). The majority of these adverse events involved cutaneous signs and/or hypotension. These findings might be taken into consideration when selecting one of these intravenous antibiotics for prophylaxis in anaesthetised dogs undergoing surgery.
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Schubert, Tracey L., Emma BH Hume, and Mark DP Willcox. "Staphylococcus aureus ocular isolates from symptomatic adverse events: antibiotic resistance and similarity of bacteria causing adverse events." Clinical and Experimental Optometry 91, no. 2 (March 2008): 148–55. http://dx.doi.org/10.1111/j.1444-0938.2007.00219.x.

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Mozafarihashjin, Mohammad, Jerome A. Leis, Lorraine Maze dit Mieusement, Liz McCreight, Susan Poutanen, Ananya Shrivastava, Jannice So, et al. "Safety, effectiveness and sustainability of a laboratory intervention to de-adopt culture of midstream urine samples among hospitalized patients." Infection Control & Hospital Epidemiology 42, no. 1 (September 2, 2020): 43–50. http://dx.doi.org/10.1017/ice.2020.385.

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AbstractObjective:To assess the safety, sustainability, and effectiveness of a laboratory intervention to reduce processing of midstream urine (MSU) cultures.Design:Prospective observational cohort.Setting:Medical and surgical inpatients in a tertiary-care hospital.Participants:The study included 1,678 adult inpatients with an order for MSU culture.Methods:From 2013 to 2019, ordered MSU cultures were not processed unless the laboratory was called. Patients were interviewed on days 0 and 4; from 2017 to 2019, day-30 follow-up was added. Primary outcome was serious adverse events due to not processing MSU cultures. Secondary outcomes were nonserious adverse events due to not processing MSU cultures, rates of MSU cultures submitted, proportion of MSU cultures processed, proportion of patients prescribed urinary tract infection (UTI)–directed antibiotics, and laboratory workload.Results:Among 912 and 459 patients followed to days 4 and 30, respectively, no serious adverse events attributable to not processing MSU cultures were identified. However, 6 patients (0.66%) had prolonged urinary symptoms potentially associated with not processing MSU cultures. We estimated that 4 patients missed having empiric antibiotics stopped in response to negative MSU cultures, and 99 antibiotic courses for asymptomatic bacteriuria (ASB) and 8 antibiotic-associated adverse events were avoided. The rate of submitted MSU samples and proportion of patients receiving empiric UTI-directed antibiotics did not change. The proportion of MSU cultures processed declined from 59% to 49% (P < .0001), and total laboratory workload was reduced by 185 hours.Conclusions:De-adopting the processing of MSU cultures from medical and surgical inpatient units is safe and sustainable, and it reduces antibiotic prescriptions for ASB at a cost of prolonged urinary symptoms in a small proportion of patients.
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Kubota, Yohei, and Toh Yoon Ezekiel Wong. "Severe Drug-Induced Agranulocytosis Successfully Treated with Recombinant Human Granulocyte Colony-Stimulating Factor." Case Reports in Medicine 2018 (2018): 1–3. http://dx.doi.org/10.1155/2018/8439791.

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When elderly patients are prescribed many different medications, the risk for developing serious adverse events should be kept in mind. One of these adverse events is agranulocytosis, which, although rare, can be life-threatening if left untreated. The majority of agranulocytosis cases are caused by drugs, including antibiotics. Here, we report a case of severe agranulocytosis in a 96-year-old woman following antibiotic therapy which was successfully managed using recombinant human granulocyte colony-stimulating factor (rhG-CSF) and the appropriate choice of antibiotics to treat her concomitant infection.
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Bruno-Murtha, Lou Ann, John Brusch, David Bor, Wenjun Li, and Deborah Zucker. "A Pilot Study of Antibiotic Cycling in the Community Hospital Setting." Infection Control & Hospital Epidemiology 26, no. 1 (January 2005): 81–87. http://dx.doi.org/10.1086/502491.

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AbstractObjective:To assess the feasibility of a quarterly antibiotic cycling program at two community hospitals and to evaluate its safety and impact on antibiotic use, expenditures, and resistance.Design:Nonrandomized, longitudinal cohort study.Setting:Two community hospitals, one teaching and one non-teaching.Patients:Adult medical and surgical inpatients requiring empiric antibiotic therapy.Intervention:We developed and implemented a treatment protocol for the empiric therapy of common infections. Between July 2000 and June 2002, antibiotics were cycled quarterly; quinolones, beta-lactam–inhibitor combinations, and cephalosporins were used. Protocol adherence, adverse drug events, nosocomial infections, antibiotic use and expenditures, resistance among clinical isolates, and length of stay were assessed during eight quarters.Results:Physicians adhered to the protocol for more than 96% of 2,494 eligible patients. No increases in nosocomial infections or adverse drug events were attributed to the cycling protocol. Antibiotic acquisition costs increased 31%; there was a 14.7% increase in antibiotic use. Length of stay declined by 1 day. Quarterly variability in the prevalence of vancomycin-resistant enterococci and ceftazidime resistance among combined gram-negative organisms were noted.Conclusions:Implementation of an antibiotic cycling program is feasible in a community hospital setting. No adverse safety concerns were identified. Antibiotic cycling was more expensive, partly due to an increase in antibiotic use to optimize initial empiric therapy. Quarterly antibiogram patterns suggested that antibiotic cycling may have impacted resistance, although the small number of isolates precluded statistical analysis. Further assessment of this approach is necessary to determine its relationship to antimicrobial resistance.
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Jing, Ying, Xue Chen, Kunyan Li, Yaoming Liu, Zhao Zhang, Yiqing Chen, Yuan Liu, et al. "Association of antibiotic treatment with immune-related adverse events in patients with cancer receiving immunotherapy." Journal for ImmunoTherapy of Cancer 10, no. 1 (January 2022): e003779. http://dx.doi.org/10.1136/jitc-2021-003779.

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BackgroundTo determine whether antibiotic treatment is a risk factor for immune-related adverse events (irAEs) across different patients with cancer receiving anti-PD-1/PD-L1 therapies.MethodsThe retrospective analysis includes clinical information from 767 patients with cancer treated at Hunan Cancer Hospital from 2017 to 2020. The pharmacovigilance data analysis includes individual cases of 38,705 safety reports from the US Food and Drug Administration Adverse Event Reporting System (FAERS) from 2014 to 2020, and 25,122 cases of safety reports from the World Health Organization database VigiBase from 2014 to 2019. All cases that received anti-PD-1/PD-L1 treatment were included. Multiomics data from patients across 25 cancer types were download from The Cancer Genome Atlas. Logistic regression and propensity score algorithm was employed to calculate OR of irAEs.ResultsRetrospective analysis of in-house patients showed that irAE potential risks are higher in all cancer (OR 2.12, 95% CI 1.38 to 3.22, false discovery rate (FDR) adjusted-p=1.93×10−3) and patients with lung cancer (OR 3.16, 95% CI 1.67 to 5.95, FDR adjusted-p=1.93×10−3) when using antibiotics. Potential risk of irAEs in patients with lung cancer with antibiotic treatment is significantly higher in FAERS (OR 1.39, 95% CI 1.21 to 1.59; FDR adjusted-p=1.62×10−5) and VigiBase (OR 1.32, 95% CI 1.09 to 1.59, FDR adjusted-p=0.05). Mechanistically, decreased microbial diversity caused by antibiotics use may increase the irAE risk through mediating the irAE-related factors.ConclusionsOur study is the first to comprehensively demonstrate the associations of irAEs and antibiotic during anti-PD-1/PD-L1 therapy across a wide spectrum of cancers by analyzing multisource data. Administration of antibiotics should be carefully evaluated in patients with cancer treated by anti-PD-1/PD-L1 to avoid potentially increasing irAE risk.
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Malfertheiner, P. "Compliance, Adverse Events and Antibiotic Resistance in Helicobacter pylori Treatment." Scandinavian Journal of Gastroenterology 28, sup196 (January 1993): 34–37. http://dx.doi.org/10.3109/00365529309098341.

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Tamma, Pranita D., Edina Avdic, David X. Li, Kathryn Dzintars, and Sara E. Cosgrove. "Association of Adverse Events With Antibiotic Use in Hospitalized Patients." JAMA Internal Medicine 177, no. 9 (September 1, 2017): 1308. http://dx.doi.org/10.1001/jamainternmed.2017.1938.

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Kokado, Ryohei, Hideharu Hagiya, Toshihiro Koyama, Eiko Matsui, Hideo Okuno, Daiichi Morii, Shigeto Hamaguchi, Hisao Yoshida, Yoshihiro Miwa, and Kazunori Tomono. "Antibiotic-associated adverse drug events at a Japanese academic hospital." Journal of Infection and Chemotherapy 25, no. 5 (May 2019): 392–95. http://dx.doi.org/10.1016/j.jiac.2018.11.002.

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Evans, R. Scott, Stanley L. Pestotnik, David C. Classen, Susan D. Horn, Sheron B. Bass, and John P. Burke. "Preventing Adverse Drug Events in Hospitalized Patients." Annals of Pharmacotherapy 28, no. 4 (April 1994): 523–27. http://dx.doi.org/10.1177/106002809402800417.

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OBJECTIVE: To use computerized adverse drug event (ADE) surveillance to help identify methods to reduce the number of ADEs in hospitalized patients. DESIGN: Prospective study of 79 719 hospitalized patients during a 44-month period. SETTING: LDS Hospital, a 520-bed tertiary care center affiliated with the University of Utah School of Medicine, Salt Lake City. INTERVENTION: Sequential study periods of at least one year each were compared. In the first period, data were collected but not reported to physicians, pharmacists, or nurses. In the subsequent study periods, three interventions (computerized alerts of drug allergies, standardized antibiotic administration rates, and timely physician notification of all ADEs) were made to reduce the number of type B (allergic or idiosyncratic reactions) and severe ADEs. RESULTS: In the first study period, we identified 56 type B ADEs during 120 213 patient days. During two subsequent study periods that included alerts to physicians of known drug allergies and standardized antibiotic administration rates, 8 type B events were identified during 113 237 patient days and 18 during 107 868 patient days, respectively (p<0.OO2). Early notification of physicians of all confirmed ADEs regardless of severity was associated with asignificant reduction of ADEs classified as severe from 41 during 113 859 patient days in the first study period to 12 during 103 071 patient days and 15 during 108 320 patient days in two subsequent study periods, respectively (p<0.00 1). CONCLUSIONS: Prospective surveillance of computer-based medical records for known drug allergies and appropriate drug administration rates can reduce the number of type B ADEs. Early ADE detection and notification of physicians permit drug and dosage changes that reduce the progression of mild and moderate ADEs to more severe conditions.
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Watanabe, Jun, Junya Shimamoto, and Kazuhiko Kotani. "The Effects of Antibiotics for Helicobacter pylori Eradication or Dapsone on Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis." Antibiotics 10, no. 2 (February 4, 2021): 156. http://dx.doi.org/10.3390/antibiotics10020156.

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Background: Chronic spontaneous urticaria (CSU) is a disease with wheals and/or angioedema. Some drugs, especially antibiotics for Helicobacter pylori (H. pylori) eradication and the sulfone antibiotic dapsone, may be candidates for treating CSU. The present study assessed the efficacy of these antibiotic therapies for CSU. Methods: Databases (MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the World Health Organization International Clinical Trials Platform Search Portal and ClinicalTrials.gov) were searched until October 2020. Study selection, data abstraction and quality assessments were independently performed using the Grading of Recommendations Assessment, Development and Evaluation approach. The outcomes were the remission of CSU-related symptoms, activities and adverse events due to antibiotics for H. pylori eradication or dapsone. Results: Nine randomized controlled trials (RCTs; 361 patients) were included. The antibiotics for H. pylori eradication increased the remission rate (risk ratio (RR) = 3.99, 95% confidence interval (CI) = 1.31 to 12.14; I2 = 0%), but dapsone did not (RR = 1.15, 95% CI = 0.74 to 1.78). Antibiotics for H. pylori eradication (standard mean difference (SMD) = 1.49, 95% CI = 0.80 to 2.18; I2 = 69%) and dapsone (SMD = 7.00, 95% CI = 6.92 to 7.08; I2 = 0%) improved symptoms. The evidence of certainty was moderate. Dapsone was associated with mild adverse events, whereas H. pylori eradication was not. Conclusion: Antibiotics, especially those for H. pylori eradication, improved the remission rate and symptoms of CSU with few adverse events. Further studies are needed.
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Nissan, Josef Hadib, Nina Naeger Murphy, Nilam Patel, Mary Borovicka, Michelle Hecker, and David Gothard. "176. Topical Antibiotic and Antiseptic Use in the Operating Room: An Opportunity for Antimicrobial Stewardship?" Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S197. http://dx.doi.org/10.1093/ofid/ofab466.378.

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Abstract Background Data suggest that topical antibiotic and antiseptic use in the operating room is common but not commonly monitored by antimicrobial stewardship programs. Although some data suggest a benefit in certain surgical procedures, the CDC and WHO advise against the routine use of topical antibiotics in surgery due to uncertainty and heterogeneity in the overall data. Methods We conducted a retrospective 28-day period prevalence study of topical antibiotic and antiseptic use during surgical procedures performed in the operating room by 6 surgical specialties at a tertiary care medical center. For the subset of patients undergoing orthopedic surgeries, we evaluated the types of topical antibiotics received and the rates of surgical site infections (SSI) and adverse drug events within 28 days of the procedure. Results Of 744 surgical procedures reviewed, topical antibiotics were used in 127 (17.1%), topical antiseptics in 71 (9.5%), and both in 18 (2.4%) (Table 1). Antiseptic use was higher in orthopedics relative to all other surgical specialties while topical antibiotic use was higher in neurosurgery. Hand, vascular and plastics had distinguishably lower use. In the orthopedic subgroup, after exclusions, 218 procedures were evaluated. Topical antibiotics were used in 42 (19.2%). Topical antibiotic therapy was more likely to be administered if prosthetic material was implanted, the procedure was emergent, or if a Staphylococcus aureus infection was present. Vancomycin was the most commonly used topical antibiotic and powder was the most commonly used type of application. As shown in table 2, SSI occurred more often when both topical antibiotics and antiseptics were applied; however, SSI events were relatively uncommon, and these were more likely to have infection present at the time of surgery. Adverse events were rare. Conclusion In our institution we noted significant variability in use of topical antibiotic and antiseptic therapy among surgical specialties as well as within the orthopedic surgical specialty. Although opportunities to standardize use/nonuse of these therapies exist, this may be challenging due to the uncertainty and heterogeneity of currently available data. Disclosures All Authors: No reported disclosures
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Kimura, Shun-ichi, Hiroshi Nakano, Tomotaka Ugai, Hidenori Wada, Ryoko Yamasaki, Yuko Ishihara, Koji Kawamura, et al. "Impact Of Systemic Antibiotic Prophylaxis In Hematopoietic Stem Cell Transplantation Recipients. A Meta-Analysis Of Randomized Controlled Trials." Blood 122, no. 21 (November 15, 2013): 4534. http://dx.doi.org/10.1182/blood.v122.21.4534.4534.

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Objectives Fever during neutropenia occurs in > 90% and 80% of allogeneic and autologous hematopoietic stem cell transplantation (HSCT) recipients, respectively. Current guidelines recommend the prophylaxis with fluoroquinolones (FQs) in HSCT patients. Although there is evidence that antibiotic prophylaxis improve clinical outcome in patients with chemotherapy-induced neutropenia, prophylactic antibiotic therapy has not been thoroughly evaluated in HSCT recipients. Therefore, we performed a meta-analysis to evaluate the impact of systemic antibiotic prophylaxis in HSCT recipients on mortality, incidence of infection and related adverse events. Data sources We identified reports that were not restricted to those in English and not restricted to published trials through PubMed, the Cochrane Library, and references of identified studies. Review Methods We included prospective, randomized studies on systemic antibiotic prophylaxis in HSCT recipients. The outcome measures included the all-cause mortality, infection-related mortality, febrile episodes, incidence of clinically or microbiologically documented infection, bacteremia, or related adverse events. The summarized odds ratios (ORs) were calculated using the Mantel–Haenszel method and the DerSimonian–Laird method. Results Seventeen trials with 1453 patients (842 autologous and 407 allogeneic HSCT recipients) were included. The percentage of autologous and allogeneic HSCT recipients was not specified in 2 trials. Systemic antibiotic prophylaxis was compared with placebo or no prophylaxis in 10 trials and with non-absorbable antibiotic in 2 trials, respectively. Systemic antibiotics other than FQs were evaluated in five out of these 12 trials. Four trials evaluated the effect of addition of antibiotics for gram positive bacteria to FQs. Remaining 1 trial compared the two different systemic antibiotic regimens, FQs versus trimethoprim sulfamethoxazole. As a result, systemic antibiotic prophylaxis reduced the incidence of febrile episodes (OR 0.16; 95 percent confidence interval [CI], 0.09-0.30), clinically or microbiologically documented infection (OR 0.41; 95% CI 0.30-0.57) and bacteremia (OR 0.37; 95% CI 0.26-0.53) without the significant effect on all-cause mortality or infection-related mortality (OR 0.89; 95% CI 0.48-1.66, OR 1.37; 95% CI 0.50-3.76, respectively). Impact of prophylaxis with FQs on mortality was inconclusive because of small number of clinical trials evaluated. Adverse events increased in patients with systemic antibiotic prophylaxis compared to controls (OR 3.32; 95% CI 1.45-7.63). In meta-regression, percentage of allogeneic HSCT recipients was not associated with each outcome measure. With regard to the comparison between different prophylactic regimens, addition of antibiotics for gram positive bacteria to FQs decreased the incidence of bacteremia (OR 0.44; 0.24-0.80) without significant effects on all-cause mortality, infection related death and febrile episodes. There was not significant, but consistent decrease in clinically or microbiologically documented infection (OR 0.55; 95% CI 0.30-1.01). There was significant increase of adverse events in patients receiving addition of antibiotics for gram positive bacteria to FQs (OR 6.65; 95% CI 2.15-20.54). Conclusions Systemic antibiotic prophylaxis successfully reduced the incidence of infection in HSCT recipients. However, there was no significant impact on mortality. Impact of prophylaxis with FQs on mortality in HSCT recipients was inconclusive because of small number of trials evaluated. Disclosures: No relevant conflicts of interest to declare.
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Ozkan, Jerome, Mark D. P. Willcox, Varsha M. Rathi, Dumpati Srikanth, Hua Zhu, Percy Lazon de la Jara, Thomas Naduvilath, and Brien A. Holden. "Effect of Antibiotic Drops on Adverse Events During Extended Lens Wear." Optometry and Vision Science 91, no. 1 (January 2014): 13–23. http://dx.doi.org/10.1097/opx.0000000000000123.

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Fowler, K. C., J. A. Duncavage, J. J. Murray, and S. Tanner. "Chronic sinusitis and intravenous antibiotic therapy: Resolution, recurrence, and adverse events." Journal of Allergy and Clinical Immunology 111, no. 2 (February 2003): S85. http://dx.doi.org/10.1016/s0091-6749(03)80220-8.

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Bonner, Loren. "Study finds antibiotic adverse drug events often bring kids to ED." Pharmacy Today 24, no. 12 (December 2018): 21. http://dx.doi.org/10.1016/j.ptdy.2018.11.012.

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Zeitler, Kristen, Ripal Jariwala, and Jose Montero. "Adverse Events Releated to Antibiotic Use in Patients with Myasthenia Gravis." Open Forum Infectious Diseases 4, suppl_1 (2017): S342. http://dx.doi.org/10.1093/ofid/ofx163.815.

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Abstract Background Myasthenia gravis is a medical condition involving the neuromuscular junction, characterized by weakness and fatigue of voluntary muscles. While the understanding of myasthenia gravis has progressed over the years, questions remain regarding which antimicrobial agents can be administered safely to these patients. Traditionally, aminoglycosides and fluoroquinolones have been avoided in this patient population, while other antimicrobials may be prescribed with caution. With minimal literature to guide practice, our aim was to review antimicrobial prescribing in patients with myasthenia gravis at our institution. Methods We conducted a retrospective chart review of adult patients 18 years of age and older with a diagnosis of myasthenia gravis who were admitted from January 2012 through December 2015. Charts were reviewed for the receipt of any antimicrobial during the course of hospitalization and any adverse events related to receipt of antimicrobial agents. Results 205 patients with a diagnosis of myasthenia gravis were admitted to our institution during the study period. 132 (64.4 %) patients were female and ages ranged from 20 to 98 with a median age of 59 years. 159 (77.6 %) patients received at least 1 dose of an antimicrobial agent during their hospitalization. It was notable that 12.2 % and 11.7 % of patients received at least 1 dose of ciprofloxacin or levofloxacin, respectively. Additionally, 3.9 % of patients received at least 1 dose of an aminoglycoside (gentamicin or tobramycin). Five patients experienced a worsening of their myasthenia gravis symptoms with antibiotic use; 2 cases involved levofloxacin and 1 case each involved ciprofloxacin, cefazolin, or clindamycin. Of note, the average duration of therapy prior to symptoms being noted was 2.6 days. Conclusion This study highlights the wide variation in antimicrobial prescribing for patients with myasthenia gravis. Our chart review identified few adverse reactions exacerbating disease symptoms related to antimicrobial use. As it is still unclear the exact mechanism for the development of reactions in select patients with myasthenia gravis, further research may be needed to elucidate this information. Disclosures All authors: No reported disclosures.
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Mitka, Mike. "Emergency Departments See High Rates of Adverse Events From Antibiotic Use." JAMA 300, no. 13 (October 1, 2008): 1505. http://dx.doi.org/10.1001/jama.300.13.1505.

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Rosdiana, Dani, Mukhyarjon Mukhyarjon, and Dewi Anggraini. "Gambaran Pemakaian Antibiotika Setelah Implementasi Pedoman Pemakaian Antibiotika di Bangsal Kenanga RSUD Arifin Achmad Provinsi Riau Periode Juni-Agustus 2016." Jurnal Ilmu Kedokteran 11, no. 1 (March 15, 2018): 7. http://dx.doi.org/10.26891/jik.v11i1.2017.7-11.

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Implementation of antibiotic guideline as part of “Antibiotic Stewardship Programs (ASPs)”, can both optimize thetreatment of infections and reduce adverse events associated with antibiotic use, antibiotic resistance and savinghospitals funds. This study describes quantitative and qualitative evaluation and cost of antibiotic use afterimplementation of antibiotic guideline in Kenanga ward Arifin Achmad General Hospital.This research was a descriptiveprospective study. All inpatients given antibiotic in Kenanga ward from June – August 2016 were evaluated. Thequantitative antibiotic use was calculated with DDD (daily define dose) meanwhile Gyssens method was used tocalculate qualitative of antibiotic use. There were 137 patients fulfilled inclusion criteria. The most antibiotic usedwere ceftriaxone, ciprofloxacin, levofloxacin, meropenem and cefoperazone. There was increased consumption ofquinolone class antibiotics. The highest DDD’s antibiotic was ceftriaxone (96.5). Qualitative measurement showedthat rational antibiotic (Gyssens category 0) was 46%, irrational (Gyssens category I - IV) was 35 % and no indicationof antibiotic use (Gyssens category V) was 19%. The total cost of antibiotics in this period were Rp 41,444,766.Afterantibiotic guideline implementation, we found that the most frequent antibiotic was ceftriaxone and irrational use ofantibiotic was still high.
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Voigt, Jeffrey, Michael Mosier, and Rabih Darouiche. "Systematic Review and Meta-analysis of Randomized Controlled Trials of Antibiotics and Antiseptics for Preventing Infection in People Receiving Primary Total Hip and Knee Prostheses." Antimicrobial Agents and Chemotherapy 59, no. 11 (August 10, 2015): 6696–707. http://dx.doi.org/10.1128/aac.01331-15.

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ABSTRACTInfection rates in primary (first-time) major joint arthroplasty continue to be a significant issue. The effect of antibiotic and antiseptic prophylaxis on outcomes for this type of surgery has not been adequately reviewed. A systematic search of the main databases for randomized controlled trials (RCTs) evaluating antibiotics and antiseptics was conducted to evaluate the predetermined endpoints of infection, adverse events, costs, quality of life, and concentration levels of antibiotics. A meta-analysis using pooled effect estimates and fixed-effect and random-effect models of risk ratios (RR), calculated with 95% confidence intervals (CI), was utilized. Thirty (30) RCTs examined the effects of antibiotic and antiseptic prophylaxis on infections after primary total hip arthroplasty (THA) (total of 11,597 participants) and total knee arthroplasty (TKA) (total of 6,141 participants). For THA, preoperative systemic intravenous (i.v.) antibiotic prophylaxis may be effective in reducing the incidence of infection after THA from 6 months to ≥5 years. For TKA, there is no RCT evidence that antibiotics and/or antiseptics have any effect on infection rate. Preoperative systemic antibiotic prophylaxis in primary THA may be effective at reducing infection rate. There is no evidence that timing, route of administration, or concentration levels have an effect on reducing infections, adverse events, or costs in THA or TKA. Many of the trials included in this study were published in the 1980s and 1990s. Thus, it would be important to replicate a number of them based on current patient demographics and incidence of bacterial resistance.
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Bigotte Vieira, Miguel, Mariana Alves, João Costa, and António Vaz-Carneiro. "Análise da Revisão Cochrane: Antibióticos Destinados ao Tratamento da Bacteriúria Assintomática. Cochrane Database Syst Rev. 2015;4:CD009534." Acta Médica Portuguesa 31, no. 2 (February 28, 2018): 76. http://dx.doi.org/10.20344/amp.10077.

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Asymptomatic bacteriuria is frequently detected in women aged up to 60 years, patients with diabetes and elderly patients. The benefit of antibiotic treatment for this condition is controversial. The objective of this Cochrane systematic review was to assess the effectiveness and safety of antibiotic treatment for asymptomatic bacteriuria in adults. A systematic review of the literature up to 24 February 2015 was performed using the Cochrane Renal Group’s Specialised Register. Randomised controlled trials (RCTs) and quasirandomised controlled trials comparing antibiotics to placebo or no treatment for asymptomatic bacteriuria in adults were included. The outcomes of interest were the development of symptomatic urinary tract infection, complications, death, adverse events, development of antibiotic resistance, bacteriological cure, and decline in kidney function. Nine studies (1614 participants) were included in this review. The incidence of symptomatic urinary tract infection, complications or death was similar between groups. Antibiotic use was significantly associated with bacteriological cure and an increase in minor adverse events. No decline in kidney function was observed with any one of the treatments. According to the results of the studies included in this revision, authors have concluded that there is no clinical benefit in treating asymptomatic bacteriuria in adults.
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Gillon, Jessica, Elizabeth Townsley, Natalia Jimenez-Truque, Kathryn Garguilo, Ritu Banerjee, and Ritu Banerjee. "892. Risk Factors for Adverse Events in Children Receiving Outpatient Antibiotic Therapy." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S23. http://dx.doi.org/10.1093/ofid/ofz359.051.

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Abstract Background Outpatient parenteral antibiotic therapy (OPAT) can decrease the length of hospital stay but is associated with adverse events (AEs). The purpose of this study was to quantify and identify risk factors for OPAT-associated AEs in children. Methods This is a retrospective, single-center study of patients aged ≤21 years discharged on OPAT from January 2016 to April 2019. Only patients with OPAT overseen by the infectious disease service were included. Medication AE’s included: rash, neutropenia, hepatitis, diarrhea, C. difficile infection, increased serum creatinine, or others. Central line AEs included: central line dysfunction, infection, rash around line site, or other. Wilcoxon rank-sum test, Pearson’s χ2 test, Fisher’s exact test, and multivariable logistic regression models were used for analyses. Results Demographic information can be found in Table 1. Among 176 patients included in the study, an AE occurred in 69 (39%). In a multivariable logistic regression model adjusting for age, county of residence, duration of OPAT, and duration line was in place, each additional day of antibiotics increased the odds of having a medication or line-related AE by 3% (OR 1.03; 95% CI 1.01–1.06; P = 0.005; Table 2). Medication AEs occurred in 30 patients (17%). The most frequent medication AEs were neutropenia (24%), rash (15%), and increased liver function tests (15%). Patients residing in a Large Fringe Metro area (suburb) had 33% lower odds of having a drug-related AE compared with those in a Large Central Metro area (OR 0.67; 95% CI 0.50 to 0.90; P = 0.008). Line AEs occurred in 46 patients (26%), with 10 patients (21%) experiencing >1 line AE. The most common line AEs were line malfunction (56.5%) and line infection (13%). Seven patients experienced both a medication AE and a central line AE. Of the 176 patients, 20 (11%) were readmitted to the hospital due to medication or line AE and an additional 25 (14%) had a healthcare visit for an AE although did not require admission. Conclusion In our region, nearly 40% of children experienced an OPAT-associated AE and line AEs were more common than medication AEs. Longer durations of IV therapy was an independent risk factor for AEs. Converting to oral antibiotic therapy as soon as feasible may reduce OPAT-associated AEs. Disclosures Ritu Banerjee, MD, PhD, Accelerate Diagnostics: Grant/Research Support; BioFire: Research Grant; Biomerieux: Research Grant; Roche: Research Grant.
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Gandhi, Tejal N., Valerie M. Vaughn, Lindsay A. Petty, Anna Conlon, Anurag N. Malani, Elizabeth Mclaughlin, Allison J. Weinmann, Danielle Osterholzer, Vineet Chopra, and Scott A. Flanders. "2893. The Michigan Hospital Medicine Safety Consortium: Improving Patient Care by Reducing Excessive Antibiotic Use in Patients Hospitalized with Community-Acquired Pneumonia." Open Forum Infectious Diseases 6, Supplement_2 (October 2019): S80—S81. http://dx.doi.org/10.1093/ofid/ofz359.171.

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Abstract Background Most patients hospitalized with community-acquired pneumonia (CAP) can be safely treated with 5 days of antibiotics, but many are not. We determined whether a hospitalist-collaborative can reduce excess antibiotic duration in patients with CAP through partnership with antibiotic stewardship teams (AST), data feedback, pay-for-performance, and sharing best practices. Methods From April 2017 to October 2018, abstractors collected data (medical record, phone calls 30-days post-discharge) on adult, non-ICU patients hospitalized with CAP at 43 hospitals in Michigan. We used a guideline-based algorithm1 to determine appropriate antibiotic duration based on patient factors (e.g., clinical stability). All hospitals received a) quarterly reports on appropriate 5-day treatment rates (2016—current), b) best practice recommendations (2017—current) including toolkit and webinar (3/2018), and c) pay-for-performance based on 5-day CAP metric (2018—current). Generalized linear mixed models were used to evaluate change over time in a) proportion of patients with CAP eligible for 5-day treatment who received 5 ± 1 days and, after adjusting for patient factors and weighting by inverse probability of treatment, b) patient outcomes 30-days post-discharge. Results Of 6,229 patients hospitalized with CAP, 4,769 (76.6%) were eligible for 5-days of antibiotic treatment; 283 (5.9%) were excluded due to inability to determine antibiotic duration. Between April 2017 and October 2018, the proportion of patients eligible for a 5-day duration of antibiotic treatment who received 5 ± 1 days increased from 19.8% (181/914) to 30.9% (207/670; P = 0.01), a relative improvement of 56.1% (Figure 1). During this time period, there were no changes in 30-day post-discharge death, readmission, emergency room visit, Clostridioides difficile infection, or provider-documented antibiotic-associated adverse-events (Table 1). However, there was a decrease (3.3% to 1.7%, P = 0.03 for change over time; relative reduction: 48.5%) in patient-reported antibiotic-associated adverse events (Figure 2). Conclusion A hospitalist collaborative partnering with AST can safely reduce excess antibiotic duration and antibiotic-associated adverse-events in hospitalized patients with CAP. Disclosures All Authors: No reported Disclosures.
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Roberts, Rebecca M., Alison P. Albert, Darcia D. Johnson, and Lauri A. Hicks. "Can Improving Knowledge of Antibiotic-Associated Adverse Drug Events Reduce Parent and Patient Demand for Antibiotics?" Health Services Research and Managerial Epidemiology 2 (January 26, 2015): 233339281456834. http://dx.doi.org/10.1177/2333392814568345.

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Butler, Anne M., Michael Durkin, Matthew R. Keller, Yinjiao Ma, William Powderly, and Margaret A. Olsen. "17. Comparative Safety of Antibiotic Therapy for Outpatient Treatment of Uncomplicated Urinary Tract Infections." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S9—S10. http://dx.doi.org/10.1093/ofid/ofaa417.016.

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Abstract Background Urinary tract infection (UTI) is one of the most common indications for outpatient antibiotic prescriptions in otherwise healthy women, yet the comparative safety of antibiotics for empirical therapy is not well established. We compared the risk of adverse drug events by antibiotic treatment regimen among premenopausal women with uncomplicated UTI. Methods Using the IBM MarketScan Commercial Database (2006–2015), we identified healthy, non-pregnant women aged 18–44 who were diagnosed with UTI and prescribed a same-day antibiotic with activity against common uropathogens. Patients were followed for outcomes with varying follow-up periods: 3 days (anaphylaxis), 14 days (acute renal failure, skin rash, urticaria/hives, nausea/vomiting, abdominal pain), 30 days (vaginitis/vulvovaginal candidiasis, non-C. difficile diarrhea) and 90 days (C. difficile diarrhea, pneumonia, tendinopathy, retinal detachment). We estimated propensity score-weighted hazard ratios (HR) and 95% confidence intervals (CI) using Cox proportional hazards models. Results Of 1,140,602 eligible women, the distribution of antibiotic receipt was fluoroquinolones (44%), trimethoprim-sulfamethoxazole (TMP/SMX) (28%), nitrofurantoin (24%), narrow-spectrum β-Lactam / β-Lactamase inhibitor combinations (“β-Lactams”) (3%), broad-spectrum β-Lactams (1%) and amoxicillin/ampicillin (1%). Of two first-line agents, we observed higher risk of outcomes among TMP/SMX vs. nitrofurantoin initiators: acute renal failure (HR 2.46, 95% CI 1.46–4.14), skin rash (HR 2.43, 95% CI 2.13–2.77), urticaria (HR 1.35, 95% CI 1.18–1.56), nausea/vomiting (HR 1.19, 95% CI 1.10–1.29) and abdominal pain (HR 1.14, 95% CI 1.09–1.19). Compared to nitrofurantoin, non-first-line agents (fluoroquinolones, broad-, and/or narrow-spectrum β-Lactams) were associated with higher risk of acute renal failure, skin rash, nausea/vomiting, abdominal pain, vaginitis/vulvovaginal candidiasis, diarrhea (C. difficile & non-C. difficile), pneumonia and tendinopathy. Conclusion The risk of adverse drug events differs widely by antibiotic agent, with substantial differences in first-line agents. Understanding antibiotic safety is critical to prevent suboptimal antibiotic prescribing and reduce adverse events. Disclosures Margaret A. Olsen, PhD, MPH, Merck (Grant/Research Support)Pfizer (Consultant, Grant/Research Support)
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Dallo, Matthew, Kavina Patel, and Adelaide A. Hebert. "Topical Antibiotic Treatment in Dermatology." Antibiotics 12, no. 2 (January 17, 2023): 188. http://dx.doi.org/10.3390/antibiotics12020188.

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Many indications in dermatology can be effectively managed with topical antibiotics, including acne vulgaris, wound infections, secondarily infected dermatitis, and impetigo. Dermatologists must be familiar with the wide spectrum of topical antibiotics available, including indications, mechanisms of action, adverse events, and spectra of activity. Dermatologists must also keep antibiotic resistance in mind when utilizing these medications. Due to the widespread use of topical antibiotics and their importance in dermatology, a literature review was performed using a systematic search of PubMed and Google Scholar with the terms topical antibiotics, skin infections, dermatology, antimicrobials, and inflammatory dermatoses to identify English-language articles published between 1965–2022 from any country. Relevant publications were manually reviewed for additional content. The following literature review will summarize the common topical antibiotics used in dermatology.
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Swords, Chloe E., Jeremy J. Wong, Kara N. Stevens, Alkis J. Psaltis, Peter J. Wormald, and Neil C. W. Tan. "The Use of Postoperative Antibiotics Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis: A Systematic Review and Meta-analysis." American Journal of Rhinology & Allergy 35, no. 5 (January 24, 2021): 700–712. http://dx.doi.org/10.1177/1945892421989142.

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Background Endoscopic sinus surgery is performed for medically recalcitrant chronic rhinosinusitis. There is no universally accepted strategy regarding post-operative antibiotics despite the high rates of usage worldwide. The aim of this study was to analyse patient-reported and objective outcomes behind antibiotic use following endoscopic sinus surgery. Methods A search of electronic databases was performed. Eligible randomised controlled trials (RCTs) and observational trials were included. The primary outcome was patient reported outcome measures. Secondary outcomes were local infections, endoscopy scores and adverse events. Meta-analysis was performed. Results Of 1045 publications identified, 7 were included in the qualitative synthesis and 5 RCTs were included in meta-analysis. Antibiotic regimens varied between studies in terms of antibiotic selection, timing commenced and duration of use. Meta-analysis suggested no significant difference between placebo and antibiotics in patient reported outcome measures (standardised mean difference (SMD) –0.215, 95% confidence interval (CI) –0.637 to 0.207) or endoscopic scores (SMD –2.86, 95% CI –0.846 to 0.273). There was no consistent definition in reporting of infection; therefore, this outcome cannot be comprehensively considered. No severe adverse events were attributable to antibiotics. Conclusions From the studies analysed, there is no level 1 evidence to suggest that antibiotics improved patient outcomes following sinus surgery. However, there was significant heterogeneity in outcome measures and no clear data exists regarding the effects of antibiotics on postoperative infections. The available evidence at present is not enough to make a recommendation in either direction. Further designed larger RCTs are required to investigate these questions in more detail.
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Butler, David F., Brian R. Lee, Sarah Suppes, Tracy Sandritter, Jason G. Newland, Lory Harte, and Jennifer L. Goldman. "Variability of surgical prophylaxis in penicillin-allergic children." Infection Control & Hospital Epidemiology 39, no. 12 (December 2018): 1480–83. http://dx.doi.org/10.1017/ice.2018.244.

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AbstractWe retrospectively evaluated the effect of penicillin adverse drug reaction (ADR) labeling on surgical antibiotic prophylaxis. Cefazolin was administered in 86% of penicillin ADR-negative (−) and 28% penicillin ADR-positive (+) cases. Broad-spectrum antibiotic use was more common in ADR(+) cases and was more commonly associated with perioperative adverse drug events.
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Stocco, Gabriele, Marianna Lucafò, and Giuliana Decorti. "Pharmacogenomics of Antibiotics." International Journal of Molecular Sciences 21, no. 17 (August 19, 2020): 5975. http://dx.doi.org/10.3390/ijms21175975.

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Although the introduction of antibiotics in medicine has resulted in one of the most successful events and in a major breakthrough to reduce morbidity and mortality caused by infectious disease, response to these agents is not always predictable, leading to differences in their efficacy, and sometimes to the occurrence of adverse effects. Genetic variability, resulting in differences in the pharmacokinetics and pharmacodynamics of antibiotics, is often involved in the variable response, of particular importance are polymorphisms in genes encoding for drug metabolizing enzymes and membrane transporters. In addition, variations in the human leukocyte antigen (HLA) class I and class II genes have been associated with different immune mediated reactions induced by antibiotics. In recent years, the importance of pharmacogenetics in the personalization of therapies has been recognized in various clinical fields, although not clearly in the context of antibiotic therapy. In this review, we make an overview of antibiotic pharmacogenomics and of its potential role in optimizing drug therapy and reducing adverse reactions.
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Thompson, Wendy, Leonardo Essado Rios, Zbys Fedorowicz, Yvonne Dailey, and Gail Douglas. "I’ve got Toothache, I need Antibiotics: a UK Perspective on Rational Antibiotic Prescribing by Dentists." Brazilian Dental Journal 29, no. 4 (August 2018): 395–99. http://dx.doi.org/10.1590/0103-6440201802200.

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Abstract Antibiotics do not cure toothache. This headline message of the United Kingdom’s (UK) Dental Antimicrobial Stewardship (AMS) toolkit’s posters and leaflets is aimed at patients; clinicians are expected to know this already. Evidence based clinical guidelines exist to set clear standards for good clinical practice yet there are barriers to compliance. The national AMS audit tool is designed for clinicians to review their management of acute dental conditions, including but not limited to the prescription of antibiotics. In this article we aim to help dental teams protect their patients and themselves from adverse events related to antibiotic prescription. It explores the emergent problem of Clostridium difficile, antibiotic resistance and severe sepsis, and considers some of the barriers, which clinicians have suggested, contribute to the unjustified prescription of antibiotics. Dentists must weigh the risks against the benefits before prescribing any antibiotic.
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Shah, Ayesha, Darrel Crawford, Daniel Burger, Neal Martin, Marjorie Walker, Nicholas J. Talley, Caroline Tallis, et al. "Effects of Antibiotic Therapy in Primary Sclerosing Cholangitis with and without Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis." Seminars in Liver Disease 39, no. 04 (July 17, 2019): 432–41. http://dx.doi.org/10.1055/s-0039-1688501.

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AbstractThe authors conducted a systematic review and meta-analysis to assess the effect of antibiotic therapy in primary sclerosing cholangitis (PSC). Effect of antibiotic therapy on Mayo PSC Risk Score (MRS), serum alkaline phosphatase (ALP), total serum bilirubin (TSB), and adverse events (AEs) rates were calculated and expressed as standardized difference of means or proportions. Five studies including 124 PSC patients who received antibiotics were included. Overall, antibiotic treatment was associated with a statistically significant reduction in ALP, MRS, and TSB by 33.2, 36.1, and 28.8%, respectively. ALP reduction was greatest for vancomycin (65.6%, p < 0.002) and smallest with metronidazole (22.7%, p = 0.18). Overall, 8.9% (95% confidence interval: 3.9–13.9) of patients had AEs severe enough to discontinue antibiotic therapy. In PSC patients, antibiotic treatment results in a significant improvement in markers of cholestasis and MRS. Antibiotics, particularly vancomycin, may have a positive effect on PSC either via direct effects on the microbiome or via host-mediated mechanisms.
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46

Townsley, Elizabeth, Jessica Gillon, Natalia Jimenez-Truque, Sophie Katz, Kathryn Garguilo, and Ritu Banerjee. "Risk Factors for Adverse Events in Children Receiving Outpatient Parenteral Antibiotic Therapy." Hospital Pediatrics 11, no. 2 (January 14, 2021): 153–59. http://dx.doi.org/10.1542/hpeds.2020-001388.

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47

Vaughn, Valerie M., Scott A. Flanders, Ashley Snyder, Anna Conlon, Mary A. M. Rogers, Anurag N. Malani, Elizabeth McLaughlin, et al. "Excess Antibiotic Treatment Duration and Adverse Events in Patients Hospitalized With Pneumonia." Annals of Internal Medicine 171, no. 3 (July 9, 2019): 153. http://dx.doi.org/10.7326/m18-3640.

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48

Fananapazir, Nafeh, Christopher Dandoy, Terri Byczkowski, Adam Lane, Rajaram Nagarajan, and Selena Hariharan. "Study of Delayed Antibiotic in Pediatric Febrile Immunocompromised Patients and Adverse Events." Hospital Pediatrics 9, no. 5 (April 23, 2019): 379–86. http://dx.doi.org/10.1542/hpeds.2018-0192.

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49

Bakhit, Mina, Mark Jones, Jenalle Baker, Ramil Nair, Kylie Yan, Chris Del Mar, and Anna Mae Scott. "Reporting of adverse events, conflict of interest and funding in randomised controlled trials of antibiotics: a secondary analysis." BMJ Open 11, no. 7 (July 2021): e045406. http://dx.doi.org/10.1136/bmjopen-2020-045406.

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ObjectivesTransparent reporting of trials is necessary to assess their internal and external validity. Currently, little is known about the quality of reporting in antibiotics trials. Our study investigates the reporting of adverse events, conflicts of interest and funding information in trials of penicillins, cephalosporins and macrolides.DesignA secondary analysis of trials included in a convenience sample of three systematic reviews.MethodsAll randomised controlled trials included in the systematic reviews were included, although duplicates were removed. Eligible trials compared the specified antibiotics to placebo, for any indication. Author pairs independently extracted the data on reporting of adverse events from parent reviews, and data on funding and conflict of interest information from the trial reports. We calculated the overall proportion of trials reporting adverse events, conflict of interest information and funding information, and their proportion before and after the publication of the Consolidated Standards of Reporting Trials (CONSORT) 2001 Statement.ResultsWe included 432 trials. Overall, 62% of trials reported adverse events of any kind, although reporting of deaths or antibiotic resistance was less frequent (20% and 37%, respectively). Conflict-of-interest information was provided in 26% of the trials, and funding information was provided in 66% of the trials. There was no significant difference in reporting of adverse events before and after the publication of CONSORT 2001 Statement (62% vs 62%, p=0.92). Conflict of interest statements were provided more frequently (2% vs 55%, p<0.001) and conflict was present more often (0% vs 14%, p<0.001). There was no difference in the provision of the information about trial funding before (62%) and after (70%) CONSORT 2001 publication.ConclusionsInformation about adverse events, conflict of interest and funding, remains under-reported in trials of antibiotics.
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Yadav, K., K. Suh, D. Eagles, V. Thiruganasambandamoorthy, G. A. Wells, and I. G. Stiell. "P160: Outpatient parenteral antibiotic therapy following emergency department treatment of non-purulent skin and soft tissue infections: a descriptive analysis." CJEM 20, S1 (May 2018): S114. http://dx.doi.org/10.1017/cem.2018.358.

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Introduction: Emergency department (ED) patients with non-purulent skin and soft tissue infections (SSTIs) requiring intravenous antibiotics may be managed via outpatient parenteral antibiotic therapy (OPAT). To date, there are no prospective studies describing the performance of an ED-to-OPAT clinic program. Furthermore, there are no studies that have examined physician rationale for intravenous therapy, despite this being a critical first step in the decision to refer to an OPAT program. Methods: We conducted a prospective observational cohort study of adults (age 18 years) with non-purulent SSTIs receiving parenteral therapy at two tertiary care EDs. Patients were excluded if they had purulent infections or could not provide consent. The emergency physician completed a form documenting rationale for intravenous therapy, infection size, and choice of antimicrobial agent, dose and duration. OPAT treatment failure was defined as hospitalization after a minimum of 48 hours of OPAT for: (i) worsening infection; (ii) peripheral intravenous line complications; or (iii) adverse antibiotic events. Patient satisfaction was assessed at a 14-day telephone follow up. Results: We enrolled a consecutive sample of 153 patients (mean age 60 years, 82 male (53.6%) and 38 (24.8%) with diabetes). A total of 137 patients (89.5%) attended their clinic appointment. Of the 101 patients prescribed cefazolin, 50.5% received 1000 mg and 48.5% received 2000 mg per day. There were low rates of OPAT treatment failure (3.9%). None of the adverse peripheral intravenous line events (9.8%) or adverse antibiotic events (7.2%) required hospitalization. Patients reported a high degree of satisfaction with timeliness of clinic referral (median score 9 out of 10) and overall care received (median score of 10 out of 10). The top 5 reasons given by physicians for selecting intravenous therapy were: clinical impression of severity (52.9%); failed oral antibiotic therapy (41.8%); diabetes (17.6%); severe pain (7.8%); and peripheral vascular disease (7.8%). Conclusion: This is the first study to identify physician rationale for the use of intravenous antibiotics for SSTIs. There was significant variability in antibiotic prescribing practices by ED physicians. This prospective study demonstrates that an ED-to-OPAT clinic program for non-purulent SSTIs is safe, has a low rate of treatment failures and results in high patient satisfaction.
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