Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID03671967

Piperacillin Tazobactam Versus Meropenem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae - a Non-inferiority Randomized Controlled Trial

Led by Rambam Health Care Campus · Updated on 2025-08-01

1084

Participants Needed

14

Research Sites

12 weeks

Total Duration

On this page

Sponsors

R

Rambam Health Care Campus

Lead Sponsor

R

Rabin Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the best treatment for bloodstream infections caused by cephalosporin-resistant Enterobacteriaceae bacteria, specifically looking at whether piperacillin-tazobactam is as effective as meropenem. The study focuses on adults with blood infections due to E. coli or Klebsiella species that are resistant to certain antibiotics but susceptible to both study drugs. The trial aims to determine if piperacillin-tazobactam is not worse than meropenem in treating these infections. Participants are randomly assigned to receive either piperacillin/tazobactam at a dose of 4.5 grams four times a day or meropenem at 1 gram three times a day. Both treatments are given to treat the bloodstream infection during the study. The trial includes patients with both community and hospital-acquired infections and excludes those with certain severe conditions or prior infections not fully treated. During the study, participants are monitored for outcomes such as death within 30 days and treatment failure within 7 days after starting treatment. Additional assessments include mortality at 14 and 90 days, microbiological outcomes, infection relapses, hospital readmissions, antibiotic use, resistance development, and adverse events. The study collects detailed data over 90 days to evaluate the safety and impact of these antibiotic treatments.

CONDITIONS

Brief Title

PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • New bloodstream infection caused by E. coli or Klebsiella species confirmed in one or more blood cultures with evidence of infection
  • Infection resistant to third generation cephalosporins but susceptible to both piperacillin-tazobactam and meropenem
  • Includes both community-acquired and hospital-acquired bloodstream infections
  • Allows inclusion if blood cultures show skin bacteria considered contaminants along with primary infection
Not Eligible

You will not qualify if you...

  • More than 72 hours have passed since the initial blood culture was taken
  • Presence of polymicrobial bacteremia with two or more different species in the same or separate blood cultures
  • Previous bacteremia or infection not fully treated with antimicrobial therapy
  • Septic shock at enrollment, defined by low blood pressure or use of vasopressor medications
  • Bloodstream infections known at enrollment such as endocarditis, osteomyelitis (unless removed), or central nervous system infections
  • Allergy to either study drug
  • Previous enrollment in this trial
  • Participation in another interventional clinical trial
  • Expected death within 48 hours of recruitment according to researcher assessment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 - Up to 30 days from randomization

Participants receive either piperacillin/tazobactam or meropenem as treatment for bloodstream infection caused by cephalosporin-resistant Enterobacteriaceae.

Visits as required during treatment period

Follow-up

Duration - Up to 90 days from randomization

Participants are monitored for treatment outcomes and any adverse events after completion of treatment.

Follow-up visits to assess health status and infection recurrence

Trial Site Locations

Total: 14 locations

1

University of Calgary, Cumming School of Medicine, O'Brien Institute for Public Health

Calgary, Alberta, Canada, T2N 4Z6

Actively Recruiting

2

Surrey Memorial Hospital - Fraser Health Authority

Surrey, British Columbia, Canada

Actively Recruiting

3

Eastern Health

St. John's, Newfoundland and Labrador, Canada

Actively Recruiting

4

Kingston General Hospital

Kingston, Ontario, Canada

Actively Recruiting

5

Jewish Genral Hospital

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

6

McGill University Health Centre

Montreal, Quebec, Canada

Actively Recruiting

7

Rambam Health Care Campus

Haifa, Israel, Israel, 3435306

Actively Recruiting

8

Soroka Medical Center

Beersheba, Israel

Actively Recruiting

9

Hadassah Medical Center

Jerusalem, Israel

Actively Recruiting

10

Meir Medical Center

Kfar Saba, Israel

Actively Recruiting

11

Sanz Medical Center-Laniado Hospital

Netanya, Israel, 42150

Actively Recruiting

12

Rabin Medical Center, Beilinson Campus

Petah Tikva, Israel

Actively Recruiting

13

Sheba Medical Center (Tel HaShomer)

Tel Aviv, Israel

Actively Recruiting

14

Sourasky Medical Center

Tel Aviv, Israel

Actively Recruiting

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Research Team

M

Mical Paul, MD

R

Roni Bitterman, MD

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

Piperacillin-tazobactam versus meropenem for treatment of bloodstream infections caused by third-generation cephalosporin-resistant Enterobacteriaceae: a study protocol for a non-inferiority open-label randomised controlled trial (PeterPen).

Roni Bitterman, Fidi Koppel, Cristina Mussini...

https://pubmed.ncbi.nlm.nih.gov/33558347