Comparing Kidney Injury Risks of Vancomycin with Piperacillin-Tazobactam Versus Vancomycin with Cefepime in Hospitalized Adults

What this Trial Is About

Researchers are evaluating the risk of acute kidney injury AKI in hospitalized patients treated with two common antibiotic combinations vancomycin with piperacillin-tazobactam VNPT and vancomycin with cefepime VNCP. Although both treatments are similarly effective against infections, there is uncertainty about their relative risk for AKI due to limitations in the standard kidney function marker, creatinine. This pragmatic, open-label, randomized trial aims to compare these regimens using more sensitive and specific biomarkers of drug-induced AKI. Participants will be randomly assigned to receive either vancomycin with piperacillin-tazobactam or vancomycin with cefepime as initial treatment. Vancomycin dosing will follow standard care protocols with individualized regimens based on body weight and kidney function, given via intermittent intravenous infusions lasting 60 to 90 minutes. Piperacillin-tazobactam and cefepime are administered by extended intravenous infusions lasting 4 hours, with dosing schedules tailored to each participants characteristics. After initial treatment, further antibiotic management is left to the treating clinicians. The study is expected to run until July 2029. Participants will be monitored with blood tests measuring serum Cystatin C five days after enrollment as the primary outcome. Additional assessments include kidney injury molecule 1 KIM1, serum creatinine levels, and evaluation of AKI at 7 and 14 days, along with major adverse kidney events at 30 and 60 days. These measures will help assess kidney function and injury during and after treatment. The trial emphasizes close monitoring and aims to provide clearer insights into kidney risks associated with these antibiotic combinations in hospitalized patients.

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