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

Study acronym: PETERPEN
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Jan 2026 to Jan 1, 2027
    • Study sites: 13 to 14
    • Study completion date: Apr 2026 to Apr 1, 2027
    v15
  2. Study sites: 11 to 13v14
  3. Primary completion date: Jan 2024 to Jan 2026
    • Study completion date: Apr 2024 to Apr 2026
    • Study sites revised (11)
    v13
  4. Study sites: 10 to 11v12
  5. Study sites: 8 to 10v11
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 2 to 8
    • Collaborators: 9 to 10
    v10
  2. Collaborators: 8 to 9v9
  3. Study sites: 1 to 2v8
  4. Re-verified, no change to tracked fieldsv7
  5. Collaborators: 18 to 8v6
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2019 to May 1, 2019
    v5
  7. Re-verified, no change to tracked fieldsv4
  8. Start date: Jan 2019 to Apr 2019
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: details revised at 1 of 12 entries
    • Collaborators: 4 to 18
    v3
  9. Secondary endpoints revised (12)
    • Study title shortened, about 5 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03671967
Lead Sponsor Rambam Health Care Campus
Collaborators: Rabin Medical Center, University of Modena and Reggio Emilia, Tel Aviv Medical Center, Meir Medical Center, Soroka University Medical Center, The Chaim Sheba Medical Center, McGill University Health Centre/Research Institute of the McGill University Health Centre, Jewish General Hospital, Canadian Institutes of Health Research (CIHR), Hadassah Medical Organization
Conditions
(from sponsor)		 Beta Lactam Resistant Bacterial Infection, Enterobacteriaceae Infections, Bacteremia
Related terms Bacteremia, Enterobacteriaceae Infections
Enrollment 1,084 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov