scholarly journals Fluoroquinolone prescribing for diabetic foot infections following an FDA Drug Safety Communication for aortic aneurysm risk

Author(s):  
Catherine Li ◽  
Nicholas J. Mercuro ◽  
Ryan W. Chapin ◽  
Howard S. Gold ◽  
Christopher McCoy

In 2018, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication regarding fluoroquinolone-associated aortic aneurysm. This quasi-experimental study assessed antibiotic prescribing for 198 hospitalized patients with diabetic foot infection. Following the warning, median inpatient fluoroquinolone days of therapy (DOT) decreased from 3 to 0 days ( P < 0.001), corresponding with increased beta-lactam DOT and OPAT enrollment. FDA communications may influence antibiotic selection and transitions of care, representing opportunities for antimicrobial stewardship.

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S115-S116
Author(s):  
Catherine Li ◽  
Nicholas J Mercuro ◽  
Ryan Chapin ◽  
Howard Gold ◽  
Christopher McCoy

Abstract Background Fluoroquinolones were commonly prescribed for hospitalized patients with diabetic foot infection (DFI) at our institution, included in 69% of empiric antibiotic regimens from 2011–2014. On December 20, 2018, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication regarding the risk of aortic aneurysm with fluoroquinolones. The objective of this study was to assess the impact of the FDA Communication on antibiotic prescribing for DFI. Methods This was a single-center quasi-experimental study of hospitalized patients initiated on antibiotics for DFI before (February-December 2018) and after (February-December 2019) the 2018 FDA Communication. Patients with concomitant infections or documented beta-lactam or fluoroquinolone allergies were excluded. The primary outcome was inpatient days of fluoroquinolone therapy. Secondary outcomes included days of beta-lactam therapy and Outpatient Parenteral Antibiotic Therapy (OPAT) enrollment. Variables were compared using the Pearson’s chi square, Fisher’s exact, and Mann Whitney U tests, as appropriate. A logistic regression was performed to identify predictors for inpatient receipt of fluoroquinolones. Results A total of 198 patients were included. Baseline characteristics were similar between groups (Table 1). After the FDA Communication, the median duration of inpatient fluoroquinolones decreased from 3 [0–5.5] to 0 [0–1] days (p&lt; 0.001). The duration of antipseudomonal beta-lactams increased from 0 [0–2] to 2 [0–6] days (p&lt; 0.001). OPAT enrollment increased from 16.5% to 29.7% (p=0.028), with a corresponding increase in peripherally inserted central catheter placement (15.5% to 25.7%, p=0.074). There was no difference in outpatient fluoroquinolone prescribing over time. Incidence of re-infection, readmission for DFI, and antibiotic adverse events were similar between groups (Table 2). Table 1 Table 2 Conclusion Inpatient fluoroquinolone prescribing for DFI decreased significantly following the 2018 FDA Communication, followed by an increase in antipseudomonal beta-lactam use and OPAT enrollment. FDA statements can influence institutional antibiotic prescribing and transitions of care decisions, representing an opportunity for education by Antimicrobial Stewardship programs. Disclosures All Authors: No reported disclosures


2019 ◽  
Vol 63 (7) ◽  
Author(s):  
Nathaniel J. Rhodes ◽  
Jamie L. Wagner ◽  
Susan L. Davis ◽  
John A. Bosso ◽  
Debra A. Goff ◽  
...  

ABSTRACT We sought to define trends in and predictors of carbapenem consumption across community, teaching, and university-affiliated hospitals in the United States and Canada. We conducted a retrospective multicenter survey of carbapenem and broad-spectrum noncarbapenem beta-lactam consumption between January 2011 and December 2013. Consumption was tabulated as defined daily doses (DDD) or as days of therapy (DOT) per 1,000 patient days (PD). Multivariate mixed-effects models were explored, and final model goodness of fit was assessed by regressions of observed versus predicted values and residual distributions. A total of 20 acute-care hospitals responded. The centers treated adult patients (n = 19/20) and pediatric/neonatal patients (n = 17/20). The majority of the centers were nonprofit (n = 17/20) and not affiliated with medical/teaching institutions (n = 11/20). The median (interquartile range [IQR]) carbapenem consumption rates were 38.8 (17.4 to 95.7) DDD/1,000 PD and 29.7 (19.2 to 40.1) DOT/1,000 PD overall. Carbapenem consumption was well described by a multivariate linear mixed-effects model (fixed effects, R2 = 0.792; fixed plus random effects, R2 = 0.974). Carbapenem consumption increased by 1.91-fold/quarter from 48.6 DDD/1,000 PD (P = 0.004) and by 0.056-fold/quarter from 45.7 DOT/1,000 PD (P = 0.93) over the study period. Noncarbapenem consumption was independently related to increasing carbapenem consumption (beta = 0.31 for increasing noncarbapenem beta-lactam consumption; P < 0.001). Regular antibiogram publication and promotion of conversion from intravenous (i.v.) to oral (p.o.) administration independently affected carbapenem consumption rates. In the final model, 58.5% of the observed variance in consumption was attributable to between-hospital differences. Rates of carbapenem consumption across 20 North American hospitals differed greatly, and the observed differences were correlated with hospital-specific demographics. Additional studies focusing on the drivers of hospital-specific carbapenem consumption are needed to determine whether these rates are justifiable.


2013 ◽  
Vol 58 (2) ◽  
pp. 558
Author(s):  
Grant H. Skrepnek ◽  
David G. Armstrong ◽  
Joseph L. Mills

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S169-S170
Author(s):  
Alex Lazo-Vasquez ◽  
Michael Piazza ◽  
Leopoldo Cordova ◽  
Lauren Bjork ◽  
Rolando A Zamora Gonzalez ◽  
...  

Abstract Background The Infectious Disease Society of America (IDSA) guidelines suggest empiric Methicillin-Resistant Staphylococcus Aureus (MRSA) coverage for Diabetic Foot Infection (DFI) with a history of MRSA infection, if local prevalence is high, or if the infection is severe. However, data suggests that there is overutilization of vancomycin in this population and this medication is associated with toxicity. MRSA nasal screen has a high negative predictive value (NPV) for ruling out MRSA in pneumonia and other sites. We performed a medication utilization evaluation (MUE) for Vancomycin IV in DFI patients who had an MRSA nares screen to determine our own NPV of this test and feasibility to use it as an antibiotic stewardship program (ASP) tool to guide vancomycin use in this population. Methods We retrospectively reviewed 224 patients from January 2015 to January 2020 who had a diagnosis of DFI and an MRSA nasal screen. 139 patients had cultures done. For the NPV, we excluded patients who had any MRSA positive culture or screen up to a year from admission (Figure 1). Figure 1. Flowchart from our medication utilization evaluation showing patient’s distribution by MRSA-screen result Results We found 148 (66%) patients with DFI who had received IV vancomycin empirically during the admission and 196 of them were MRSA-nares negative (Figure 2). The average days of therapy (DOT) in the MRSA-nares negative patients was 5.2 days vs 4.8 in the MRSA-nares positive patients. Out of the 139 patients with a negative MRSA nasal swab, 124 had no MRSA in cultures, yielding an NPV of 89%. If we considered only the deep cultures, the NPV increased to 90%. Figure 2. Number of patients who received IV vancomycin grouped by MRSA-screen result Conclusion We identified overutilization of IV vancomycin in patients with a diagnosis of DFI in our institution. Also, our NPV of the MRSA-nasal screening to rule out MRSA infection in DFI was high at 89% similar to previous studies. Based on these findings, we plan to implement a local ASP protocol (Figure 3) using MRSA nasal swab screen to decrease the empiric use of vancomycin. The results of these efforts will be analyzed and published in future iterations with the hopes to share this knowledge to reduce the use of IV vancomycin in this population in other centers. Figure 3. Protocol draft to be used as an ASP tool to guide IV vancomycin de-escalation based on MRSA-nasal screen for DFI patients Disclosures All Authors: No reported disclosures


2018 ◽  
Vol 108 (6) ◽  
pp. 528-531 ◽  
Author(s):  
Andrew J. Hale ◽  
Emily Vicks ◽  
Mary T. LaSalvia ◽  
John M. Giurini ◽  
Adolf W. Karchmer

Diabetic foot infections are a common cause of morbidity and mortality in the United States, and successful treatment often requires an aggressive and prolonged approach. Recent work has elucidated the importance of appropriate therapy for a given severity of diabetic foot infection, and highlighted the ongoing risk such patients have for subsequent invasive life-threatening infection should diabetic foot ulcers fail to heal. The authors describe the case of a man with diabetes who had prolonged, delayed healing of a diabetic foot ulcer. The ulcer subsequently became infected by methicillin-resistant Staphylococcus aureus (MRSA). The infection was treated conservatively with oral therapy and minimal debridement. Several months later, he experienced MRSA bloodstream infection and complicating endocarditis. The case highlights the ongoing risk faced by patients when diabetic foot ulcers do not heal promptly, and emphasizes the need for aggressive therapy to promote rapid healing and eradication of MRSA.


2018 ◽  
Vol 12 (05) ◽  
pp. 347-351 ◽  
Author(s):  
Michele Obeid ◽  
Eric Moughames ◽  
Petra Aboulhosn ◽  
Rashad Madi ◽  
Maya Farah ◽  
...  

Introduction: Approximately 80% of diabetes-related lower extremity amputations are preceded by a foot ulcer. Global studies on the epidemiology of diabetic foot ulcer (DFU) infections and guidelines detailing the most common pathogens and their respective antimicrobial susceptibilities are available. While Gram-positive cocci, mainly Staphylococcus species (spp.), were the most common organisms cultured from DFU in the United States, the Gram-negative Pseudomonas spp. were found to be the most common in some Middle Eastern countries. In Lebanon, however, such studies remain scarce. This study, conducted in Lebanon, investigated the most common organisms in DFU infections and their antimicrobial profiles. Methodology: We collected data from all documented diabetic foot infections between January 2015 and March 2016, 128 participants total, from 5 different hospitals in various regions of Lebanon. Results: Among all isolates, Enterobacteriaceae (42%), Pseudomonas spp. (18.6%) and methicillin-sensitive Staphylococcus aureus (MSSA) (15.3%) were the most frequent bacteria. In addition, 72% of Pseudomonas spp. were susceptible to ciprofloxacin and 63.6% of Enterobacteriaceae were susceptible to either amoxicillin/clavulanate or ciprofloxacin, 91% were susceptible to piperacillin/tazobactam. Methicillin-resistant Staphylococcus aureus (MRSA) was only found in hospitalized patients or those who received prior antibiotics. Polymicrobial infections were documented in only 38% of patients. Conclusion: In Lebanon, the most appropriate empirical oral outpatient treatment would be a combination of amoxicillin/clavulanate and ciprofloxacin. As for admitted patients who have failed the oral regimen, piperacillin/tazobactam would then be the treatment of choice.


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