Actively Recruiting
A Pragmatic Clinical Trial Comparing the Risk of Acute Kidney Injury During Treatment With Vancomycin and Piperacillin-Tazobactam vs. Vancomycin and Cefepime in Hospitalized Patients
Led by University of Pennsylvania · Updated on 2026-02-13
750
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hospitalized patients with suspected or confirmed infection are commonly treated with vancomycin (VN) in combination with either piperacillin-tazobactam (PT) or cefepime (CP). Although these regimens have similar effectiveness, recent observational evidence suggests they may differ in terms of the risk for acute kidney injury (AKI). Interpretation of existing evidence is complicated by the limitations of creatinine, the standard biomarker used to monitor kidney function, which has poor sensitivity and specificity for drug induced AKI. To address this important knowledge gap, the investigators propose to conduct a pragmatic, open-label, non-inferiority trial that will examine the comparative risk of AKI between these standard-of-care antibiotic combinations using sensitive and specific markers of drug-induced AKI. We hypothesize that the regimen of VN in combination with PT (VN+PT) is noninferior to the regimen of VN in combination with CP (VN+CP) in terms of AKI risk.
CONDITIONS
Official Title
A Pragmatic Clinical Trial Comparing the Risk of Acute Kidney Injury During Treatment With Vancomycin and Piperacillin-Tazobactam vs. Vancomycin and Cefepime in Hospitalized Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of at least 18 years
- Suspected or confirmed infection where vancomycin with piperacillin-tazobactam or vancomycin with cefepime was prescribed
- Treating clinician considers both antibiotic combinations as acceptable treatments
- Treating clinician anticipates at least 48 hours of antibiotic treatment
You will not qualify if you...
- Dialysis dependence or documented end stage kidney disease
- Acute kidney injury at baseline
- Expected survival less than 24 hours or presence of do not resuscitate orders
- History of antibiotic-resistant organisms in the past 90 days
- Documented allergy to vancomycin, cephalosporins, or penicillin
- Suspected central nervous system infection
- Inability to provide informed consent or lack of proxy for consent
- Prisoners or incarcerated individuals
- Known pregnancy or breastfeeding
- Previous enrollment in this study
- Receipt of vancomycin, piperacillin-tazobactam, or cefepime for more than 24 hours within the preceding 7 days (one-time doses allowed prior to randomization if enrolled within 12 hours)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
T
Todd Miano, PharmD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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