1084 Participants Needed

Piperacillin/Tazobactam vs Meropenem for Bacterial Blood Infections

(PETERPEN Trial)

Recruiting at 13 trial locations
RB
MP
Overseen ByMical Paul, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Rambam Health Care Campus
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Piperacillin/Tazobactam vs Meropenem for bacterial blood infections?

Research shows that Piperacillin/Tazobactam is effective against various bacteria, including those that produce beta-lactamase (an enzyme that makes bacteria resistant to some antibiotics), and is particularly active against Pseudomonas aeruginosa. Meropenem is also highly effective against resistant bacteria like Escherichia coli and Klebsiella pneumoniae, making both drugs valuable options for treating serious infections.12345

What safety information is available for Piperacillin/Tazobactam and Meropenem?

Piperacillin/Tazobactam can cause side effects like diarrhea, liver dysfunction, and in rare cases, agranulocytosis (a drop in white blood cells). It may also lead to acute kidney injury, especially when used with vancomycin. Meropenem is generally considered safe, but like all antibiotics, it can have side effects, which should be discussed with a healthcare provider.16789

How does the drug Piperacillin/Tazobactam differ from other treatments for bacterial blood infections?

Piperacillin/Tazobactam is unique because it combines a broad-spectrum penicillin with a beta-lactamase inhibitor, making it effective against bacteria that produce enzymes (beta-lactamases) which typically resist antibiotics. This combination is particularly useful for treating serious infections caused by resistant bacteria.12101112

What is the purpose of this trial?

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.

Research Team

RB

Roni Bitterman, MD

Principal Investigator

Rambam Health Care Campus

MP

Mical Paul, MD

Principal Investigator

Rambam Health Care Campus

LL

Leonard Leibovici, MD

Principal Investigator

Rabin Medical Center

CM

Cristina Mussini, MD

Principal Investigator

University of Modena and Reggio Emilia

NE

Noa Eliakim-Raz, MD

Principal Investigator

Rabin Medical Center, Beilinson Campus

Eligibility Criteria

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.

Inclusion Criteria

The infection I have is resistant to certain antibiotics but can be treated with PTZ and meropenem.
I have a blood infection caused by E. coli or Klebsiella, possibly with other non-harmful bacteria.
I have a blood infection, whether caught at home or in the hospital.
See 1 more

Exclusion Criteria

It's been over 72 hours since my first blood culture was taken.
I have had very low blood pressure or needed strong medicine to increase it recently.
Polymicrobial bacteremia. Polymicrobial bacteremia will be defined as either growth of two or more different species of microorganisms in the same blood culture, or growth of different species in two or more separate blood cultures within the same episode
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either meropenem or piperacillin-tazobactam for bloodstream infections

14 days

Follow-up

Participants are monitored for microbiological failure, adverse events, and development of resistance

90 days

Treatment Details

Interventions

  • Meropenem
  • Tazobactam
Trial Overview 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: piperacillin tazobactamExperimental Treatment1 Intervention
Group II: meropenemActive Control1 Intervention

Meropenem is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Meropenem for:
  • Intra-abdominal infections
  • Skin and skin structure infections
  • Nosocomial pneumonia
  • Urinary tract infections
  • Meningitis
🇺🇸
Approved in United States as Merrem for:
  • Complicated skin and skin structure infections
  • Intra-abdominal infections
  • Bacterial meningitis
🇨🇦
Approved in Canada as Meropenem for:
  • Intra-abdominal infections
  • Skin and skin structure infections
  • Nosocomial pneumonia
  • Urinary tract infections
🇯🇵
Approved in Japan as Meropenem for:
  • Intra-abdominal infections
  • Skin and skin structure infections
  • Nosocomial pneumonia
  • Urinary tract infections
  • Meningitis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rambam Health Care Campus

Lead Sponsor

Trials
513
Recruited
350,000+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials
476
Recruited
170,000+

Meir Medical Center

Collaborator

Trials
406
Recruited
90,500+

University of Modena and Reggio Emilia

Collaborator

Trials
99
Recruited
33,800+

Hadassah Medical Organization

Collaborator

Trials
729
Recruited
186,000+

Tel Aviv Medical Center

Collaborator

Trials
29
Recruited
8,100+

Soroka University Medical Center

Collaborator

Trials
192
Recruited
57,200+

Jewish General Hospital

Collaborator

Trials
144
Recruited
283,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Rabin Medical Center

Collaborator

Trials
423
Recruited
149,000+

Findings from Research

In an emulated trial of 121 patients with bloodstream infections caused by ceftriaxone-nonsusceptible E. coli or Klebsiella spp., the mortality rates for piperacillin-tazobactam (17.1%) and meropenem (15.4%) were similar, suggesting that piperacillin-tazobactam may be a viable alternative to meropenem for treatment.
The mortality rate in this emulated trial was significantly higher than in the original MERINO trial, indicating that patient outcomes may vary based on population characteristics and highlighting the importance of addressing biases in clinical trial methodologies.
Emulating the MERINO randomised control trial using data from an observational cohort and trial of rapid diagnostic (BSI-FOO).Evans, RN., Harris, J., Rogers, CA., et al.[2022]
The combination drug TAZ/PIPC demonstrated strong antibacterial efficacy, with a total efficacy rate of 93.9% in treating various infectious diseases in 33 pediatric cases, showing no cases of treatment failure.
TAZ/PIPC was well-tolerated, with only 11.4% of patients experiencing diarrhea as an adverse reaction, indicating a favorable safety profile for this treatment.
[Basic and clinical studies on tazobactam/piperacillin in pediatric field].Motohiro, T., Nagai, K., Yamada, T., et al.[2018]
Meropenem and heparin maintained over 90% of their initial concentration in most peritoneal dialysis solutions when stored at 4°C for 168 hours, but caution is advised as stability was suboptimal in pH-neutral solutions.
Piperacillin/tazobactam and heparin showed excellent stability across all tested peritoneal dialysis solutions, with heparin retaining over 98% of its anticoagulant activity throughout the study, indicating it is a reliable option for use in combination.
Stability of Meropenem and Piperacillin/Tazobactam with Heparin in Various Peritoneal Dialysis Solutions.Mendes, K., Harmanjeet, H., Sedeeq, M., et al.[2020]

References

Emulating the MERINO randomised control trial using data from an observational cohort and trial of rapid diagnostic (BSI-FOO). [2022]
[Basic and clinical studies on tazobactam/piperacillin in pediatric field]. [2018]
Stability of Meropenem and Piperacillin/Tazobactam with Heparin in Various Peritoneal Dialysis Solutions. [2020]
Susceptibility of bacterial isolates from Turkey--a report from the Meropenem Yearly Susceptibility Test Information Collection (MYSTIC) Program. [2022]
[Development of beta-lactamase inhibitors]. [2018]
Piperacillin-sulbactam versus piperacillin-tazobactam: a multicentre, randomised, single-blind, controlled clinical trial. [2018]
A puerperal patient with agranulocytosis during tazobactam / piperacillin administration : A case report. [2021]
Meropenem versus piperacillin-tazobactam as empiric therapy for febrile neutropenia in pediatric oncology patients. [2022]
Acute kidney injury associated with piperacillin-tazobactam versus other antibiotics combined with vancomycin in critically ill patients: A retrospective cohort study. [2023]
Contribution of β-lactamase and efflux pump overproduction to tazobactam-piperacillin resistance in clinical isolates of Escherichia coli. [2021]
Effectiveness and safety of generic formulation of piperacillin/tazobactam (Astaz-P) for treatment of infected patients at Siriraj Hospital. [2018]
[Fundamental and clinical studies on tazobactam/piperacillin in the pediatric field]. [2018]
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