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

No results posted yet for this study

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

Meropenem

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03671967 on ClinicalTrials.gov