PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)
NCT03671967 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1084
Last updated 2025-08-01
Summary
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.
Conditions
- Beta Lactam Resistant Bacterial Infection
- Enterobacteriaceae Infections
- Bacteremia
Interventions
- DRUG
-
Piperacillin/tazobactam
4.5 grams QID
- DRUG
-
1 gram TID
Sponsors & Collaborators
-
Rabin Medical Center
collaborator OTHER -
University of Modena and Reggio Emilia
collaborator OTHER -
Tel Aviv Medical Center
collaborator OTHER -
Meir Medical Center
collaborator OTHER -
Soroka University Medical Center
collaborator OTHER -
The Chaim Sheba Medical Center
collaborator OTHER -
McGill University Health Centre/Research Institute of the McGill University Health Centre
collaborator OTHER -
Jewish General Hospital
collaborator OTHER -
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Hadassah Medical Organization
collaborator OTHER -
Rambam Health Care Campus
lead OTHER
Principal Investigators
-
Roni Bitterman, MD · Rambam Health Care Campus
-
Mical Paul, MD · Rambam Health Care Campus
-
Leonard Leibovici, MD · Rabin Medical Center
-
Cristina Mussini, MD · University of Modena and Reggio Emilia
-
Noa Eliakim-Raz, MD · Rabin Medical Center, Beilinson Campus
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-01
- Primary Completion
- 2027-01-01
- Completion
- 2027-04-01
Countries
- Canada
- Israel
Study Locations
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