Comparing kidney risk of vancomycin with piperacillin-tazobactam versus vancomycin with cefepime in hospitalized adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pragmatic, open-label, non-inferiority trial conducted in hospitalized adults who are started on vancomycin plus either piperacillin-tazobactam or cefepime as part of routine care. The trial compares the two standard antibiotic combinations for their risk of causing acute kidney injury using more sensitive and specific biomarkers of drug-induced kidney injury rather than relying only on creatinine. Eligible patients are adults for whom the treating clinician considers either combination acceptable and who are expected to receive at least 48 hours of therapy; patients with baseline AKI, dialysis dependence, recent resistant organisms, or relevant allergies are excluded. The design aims to produce real-world evidence that can directly inform antibiotic choice in hospitals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age of at least 18 years
2. 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
3. The treating clinician considers both vancomycin with piperacillin- tazobactam or vancomycin with cefepime as acceptable treatment
4. The treating clinician anticipates at least 48 hours of antibiotic treatment

Exclusion Criteria:

1. Dialysis dependence or documented end stage kidney disease
2. AKI at baseline
3. Expected survival \<24 hours and/or presence of do not resuscitate orders
4. 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)
5. Documented allergy to vancomycin, cephalosporins, or penicillin
6. Suspected central nervous system infection
7. Inability to provide informed consent or lack of proxy for consent
8. Prisoners/incarcerated individuals
9. Known pregnancy or breastfeeding
10. Previous enrollment in this study
11. 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.

Where it's running

• University of Pennsylvania Health System
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Todd Miano, PharmD, PhD
• Email: todd.miano@pennmedicine.upenn.edu
• Phone: 215-573-5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.