Kidney injury molecule-1 outperforms traditional biomarkers of kidney injury in preclinical biomarker qualification studies.
Vishal S Vaidya, Josef S Ozer, Frank Dieterle...
https://pubmed.ncbi.nlm.nih.gov/20458318Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06954129
Markers of Nephrotoxicity During Treatment With Antibiotic Combinations: A Pragmatic Clinical Trial
Led by University of Pennsylvania · Updated on 2026-02-13
750
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
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 (VN+PT) and vancomycin with cefepime (VN+CP). 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 participant's 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.
CONDITIONS
Brief 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
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age of at least 18 years
- Suspected or confirmed infection requiring treatment with vancomycin combined with piperacillin-tazobactam or cefepime as prescribed by a treating clinician
- Treating clinician considers both antibiotic combinations acceptable
- Anticipated antibiotic treatment duration of at least 48 hours
You will not qualify if you...
- Dependence on dialysis or documented end stage kidney disease
- Acute kidney injury present at baseline
- Expected survival less than 24 hours or presence of do not resuscitate orders
- History of antibiotic-resistant organisms 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 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 within 12 hours before enrollment)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - At least 48 hours
Participants receive treatment with either Vancomycin combined with Piperacillin-Tazobactam or Vancomycin combined with Cefepime as prescribed by their treating clinicians.
Daily visits during treatment
Follow-up
Duration - Up to 60 days
Participants are followed to monitor kidney function and major adverse kidney events after treatment ends.
Visits at 7, 14, 30, and 60 days post enrollment
Trial Site Locations
Total: 1 location
1
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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Research Team
T
Todd Miano, PharmD, PhD
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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Published Research Related To This Trial
Early detection of acute renal failure by serum cystatin C.
Stefan Herget-Rosenthal, Günter Marggraf, Johannes Hüsing...
https://pubmed.ncbi.nlm.nih.gov/15327406Rapid detection of acute kidney injury by plasma cystatin C in the intensive care unit.
Maryam Nejat, John W Pickering, Robert J Walker...
https://pubmed.ncbi.nlm.nih.gov/20350927Acute kidney injury following the concurrent administration of antipseudomonal β-lactams and vancomycin: a network meta-analysis.
I Bellos, V Karageorgiou, V Pergialiotis...
https://pubmed.ncbi.nlm.nih.gov/32222460Lack of synergistic nephrotoxicity between vancomycin and piperacillin/tazobactam in a rat model and a confirmatory cellular model.
Gwendolyn M Pais, Jiajun Liu, Sean N Avedissian...
https://pubmed.ncbi.nlm.nih.gov/32011685Piperacillin-Tazobactam Added to Vancomycin Increases Risk for Acute Kidney Injury: Fact or Fiction?
Sean N Avedissian, Gwendolyn M Pais, Jiajun Liu...
https://pubmed.ncbi.nlm.nih.gov/31833540Cefepime vs Piperacillin-Tazobactam in Adults Hospitalized With Acute Infection: The ACORN Randomized Clinical Trial.
Edward T Qian, Jonathan D Casey, Adam Wright...
https://pubmed.ncbi.nlm.nih.gov/37837651Association of vancomycin plus piperacillin-tazobactam with early changes in creatinine versus cystatin C in critically ill adults: a prospective cohort study.
Todd A Miano, Sean Hennessy, Wei Yang...
https://pubmed.ncbi.nlm.nih.gov/35833959Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016.
Andrew Rhodes, Laura E Evans, Waleed Alhazzani...
https://pubmed.ncbi.nlm.nih.gov/28101605Sepsis and septic shock.
Maurizio Cecconi, Laura Evans, Mitchell Levy...
https://pubmed.ncbi.nlm.nih.gov/29937192