Piperacillin/Tazobactam vs Meropenem for Bacterial Blood Infections
(PETERPEN Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug Piperacillin/Tazobactam vs Meropenem for bacterial blood infections?
Research shows that Piperacillin/Tazobactam is effective against various bacteria, including those that produce beta-lactamase (an enzyme that makes bacteria resistant to some antibiotics), and is particularly active against Pseudomonas aeruginosa. Meropenem is also highly effective against resistant bacteria like Escherichia coli and Klebsiella pneumoniae, making both drugs valuable options for treating serious infections.12345
What safety information is available for Piperacillin/Tazobactam and Meropenem?
Piperacillin/Tazobactam can cause side effects like diarrhea, liver dysfunction, and in rare cases, agranulocytosis (a drop in white blood cells). It may also lead to acute kidney injury, especially when used with vancomycin. Meropenem is generally considered safe, but like all antibiotics, it can have side effects, which should be discussed with a healthcare provider.16789
How does the drug Piperacillin/Tazobactam differ from other treatments for bacterial blood infections?
Piperacillin/Tazobactam is unique because it combines a broad-spectrum penicillin with a beta-lactamase inhibitor, making it effective against bacteria that produce enzymes (beta-lactamases) which typically resist antibiotics. This combination is particularly useful for treating serious infections caused by resistant bacteria.12101112
What is the purpose of this trial?
Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae blood-stream infection are lacking. Observational studies show conflicting results when comparing treatment with combination beta-lactam-beta-lactamase inhibitor and carbapenems. The investigators aim to evaluate the effect of definitive treatment with meropenem vs. piperacillin-tazobactam on the outcome of patients with bacteremia due to cephalosporin-non-susceptible Enterobacteriaceae. The investigators hypothesize that piperacillin-tazobactam is non-inferior to meropenem.
Research Team
Roni Bitterman, MD
Principal Investigator
Rambam Health Care Campus
Mical Paul, MD
Principal Investigator
Rambam Health Care Campus
Leonard Leibovici, MD
Principal Investigator
Rabin Medical Center
Cristina Mussini, MD
Principal Investigator
University of Modena and Reggio Emilia
Noa Eliakim-Raz, MD
Principal Investigator
Rabin Medical Center, Beilinson Campus
Eligibility Criteria
Adults over 18 with bloodstream infections caused by specific bacteria (E. coli or Klebsiella spp.) resistant to certain antibiotics but susceptible to Piperacillin/tazobactam and Meropenem can join. Excluded are those with septic shock, polymicrobial bacteremia, certain severe infections like endocarditis, allergies to study drugs, previous trial participation, or other clinical trials.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either meropenem or piperacillin-tazobactam for bloodstream infections
Follow-up
Participants are monitored for microbiological failure, adverse events, and development of resistance
Treatment Details
Interventions
- Meropenem
- Tazobactam
Meropenem is already approved in European Union, United States, Canada, Japan for the following indications:
- Intra-abdominal infections
- Skin and skin structure infections
- Nosocomial pneumonia
- Urinary tract infections
- Meningitis
- Complicated skin and skin structure infections
- Intra-abdominal infections
- Bacterial meningitis
- Intra-abdominal infections
- Skin and skin structure infections
- Nosocomial pneumonia
- Urinary tract infections
- Intra-abdominal infections
- Skin and skin structure infections
- Nosocomial pneumonia
- Urinary tract infections
- Meningitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rambam Health Care Campus
Lead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Meir Medical Center
Collaborator
University of Modena and Reggio Emilia
Collaborator
Hadassah Medical Organization
Collaborator
Tel Aviv Medical Center
Collaborator
Soroka University Medical Center
Collaborator
Jewish General Hospital
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Rabin Medical Center
Collaborator