NCT03671967 PipEracillin Tazobactam Versus mERoPENem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae (PETERPEN)
| NCT ID | NCT03671967 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rambam Health Care Campus |
| Condition | Beta Lactam Resistant Bacterial Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,084 participants |
| Start Date | 2019-05-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,084 participants in total. It began in 2019-05-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adults (age ≥ 18 years) 2. New onset BSI due to E. coli or Klebsiella spp. in one or more blood cultures associated with evidence of infection. 3. 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). 4. Both community and hospital-acquired bacteremias will be included. 5. We will permit the inclusion of bacteremias due to E. coli or Klebsiella spp. with concomitant growth in blood of skin commensals considered as contaminants. Exclusion Criteria: 1. More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.). 2. 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. 3. Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode. 4. 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. 5. BSI due to specific infections known at the time of randomization: 1. Endocarditis / endovascular infections 2. Osteomyelitis (not resected) 3. Central nervous system infections 6. Allergy to any of the study drugs confirmed by history taken by the investigator 7. Previous enrollment in this trial 8. Concurrent participation in another interventional clinical trial 9. Imminent death (researcher's assessment of expected death within 48 hrs. of recruitment)
Contact & Investigator
Roni Bitterman, MD
PRINCIPAL INVESTIGATOR
Rambam Health Care Campus
Frequently Asked Questions
Who can join the NCT03671967 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Beta Lactam Resistant Bacterial Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03671967 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03671967 currently recruiting?
Yes, NCT03671967 is actively recruiting participants. Contact the research team at m_paul@rambam.health.gov.il for enrollment information.
Where is the NCT03671967 trial being conducted?
This trial is being conducted at Calgary, Canada, Surrey, Canada, St. John's, Canada, Kingston, Canada and 10 additional locations.
Who is sponsoring the NCT03671967 clinical trial?
NCT03671967 is sponsored by Rambam Health Care Campus. The principal investigator is Roni Bitterman, MD at Rambam Health Care Campus. The trial plans to enroll 1,084 participants.