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Carbapenem

Piperacillin/Tazobactam vs Meropenem for Bacterial Blood Infections (PETERPEN Trial)

Phase 4
Recruiting
Led By Roni Bitterman, MD
Research Sponsored by Rambam Health Care Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The microorganism will have to be non-susceptible to third generation cephalosporins (ceftriaxone and ceftazidime) and susceptible to both PTZ and meropenem (see microbiological methods)
Both community and hospital-acquired bacteremias will be included
Must not have
Patients with septic shock at the time of enrollment and randomization, defined as at least 2 measurements of systolic blood pressure < 90 mmHg and/or use of vasopressors (dopamine>15μg/kg/min, adrenalin>0.1μg/kg/min, noradrenalin>0.1μg/kg/min, vasopressin any dose) in the 12 hours prior to randomization. In the absence of the use of vasopressors, a systolic blood pressure <90 would need to represent a deviation for the patient's known normal blood pressure
Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days and 90 days from randomization
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether piperacillin-tazobactam is as good as meropenem for treating blood-stream infections caused by bacteria that are resistant to cephalosporins.

Who is the study for?
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.
What is being tested?
The PETERPEN trial is testing whether Piperacillin/tazobactam is as effective as Meropenem in treating bloodstream infections from cephalosporin-resistant Enterobacteriaceae. It's a head-to-head comparison of these two antibiotic treatments.
What are the potential side effects?
Possible side effects include allergic reactions, gastrointestinal issues like nausea and diarrhea, headache, skin rash or itching. Both antibiotics may also affect liver enzymes and white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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The infection I have is resistant to certain antibiotics but can be treated with PTZ and meropenem.
Select...
I have a blood infection, whether caught at home or in the hospital.
Select...
I have a new blood infection caused by E. coli or Klebsiella.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had very low blood pressure or needed strong medicine to increase it recently.
Select...
I have an ongoing infection and haven't finished my antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days and 90 days from randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days and 90 days from randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adverse events
Carriage of carbapenemase-producing Enterobacteriaceae (CPE) and non-CPE carbapenem-resistant Enterobacteriaceae in-hospital
Development of resistance
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: piperacillin tazobactamExperimental Treatment1 Intervention
Group II: meropenemActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Piperacillin
FDA approved

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
470 Previous Clinical Trials
165,877 Total Patients Enrolled
Meir Medical CenterOTHER
404 Previous Clinical Trials
89,039 Total Patients Enrolled
University of Modena and Reggio EmiliaOTHER
94 Previous Clinical Trials
31,835 Total Patients Enrolled

Media Library

Meropenem (Carbapenem) Clinical Trial Eligibility Overview. Trial Name: NCT03671967 — Phase 4
Meropenem (Carbapenem) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03671967 — Phase 4
~176 spots leftby Jan 2026
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