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PipEracillin/Tazobactam Versus mERoPENem for Treatment of AmpC Producing Blood Stream Infections

NCT05355350 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-07-24

No results posted yet for this study

Summary

Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacterales bloodstream 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 Injection

4.5 grams QID

DRUG

Meropenem

1 gram TID

Sponsors & Collaborators

  • The Chaim Sheba Medical Center

    collaborator OTHER

  • Rabin Medical Center

    collaborator OTHER

  • Hadassah Medical Organization

    collaborator OTHER

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Mical Paul, MD · Rambam Health Care Campus

  • Dafna Yahav, MD · Sheba Tel HaShomer Medical Campus

  • Alaa Atamna, MD · Rabin Medical Center, Beilinson Campus

  • Roni Bitterman, MD · Rambam Health Care Campus

  • Noa Eliakim-Raz, MD · Rabin Medical Center, Beilinson Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2025-07-21
Completion
2025-07-21

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

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 NCT05355350 on ClinicalTrials.gov