Status:
NOT_YET_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
Lead Sponsor:
University of Pennsylvania
Conditions:
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Age of at least 18 years
- Suspected or confirmed infection based on clinical criteria, for which vancomycin with piperacillin-tazobactam or vancomycin with cefepime was prescribed by the treating clinician, as evidenced by orders being placed in the electronic health record
- The treating clinician considers both vancomycin with piperacillin- tazobactam or vancomycin with cefepime as acceptable treatment
- The treating clinician anticipates at least 48 hours of antibiotic treatment
Exclusion
- Dialysis dependence or documented end stage kidney disease
- AKI at baseline
- Expected survival \<24 hours and/or presence of do not resuscitate orders
- History of antibiotic-resistant organisms (microbiological culture results showing bacterial isolates with resistant or intermediate susceptibility to any study drug within the prior 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/incarcerated individuals
- Known pregnancy or breastfeeding
- Previous enrollment in this study
- Receipt of vancomycin, piperacillin-tazobactam, or cefepime for \>24 hours within the preceding 7 days. At the time of screening, one-time doses of vancomycin, with or without piperacillin-tazobactam, or cefepime, will be allowed prior to randomization to avoid treatment delays; such patients must be enrolled within twelve hours of antibiotic administration.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT06954129
Start Date
October 1 2025
End Date
July 1 2029
Last Update
May 1 2025
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