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

Launched by RAMBAM HEALTH CARE CAMPUS · Sep 12, 2018

Keywords

ClinConnect Summary

The PETERPEN clinical trial is studying the effectiveness of two antibiotics, piperacillin-tazobactam and meropenem, for treating bloodstream infections caused by certain bacteria that are resistant to some common antibiotics. The goal is to find out if piperacillin-tazobactam can work just as well as meropenem for patients with these specific infections. This trial is open to adults aged 18 and older who have recently developed a bloodstream infection from bacteria like E. coli or Klebsiella that are not susceptible to certain third-generation antibiotics but can be treated with the medications being tested.

Participants in this study will have a chance to receive one of the two antibiotics as part of their treatment. To be eligible, they need to have a new infection confirmed by blood tests, and they must not be critically ill or have other specific infections that would complicate their care. The trial is currently recruiting participants, so those who are interested should talk to their healthcare provider about the possibility of joining. Overall, this study aims to improve treatment options for serious infections and help healthcare professionals make better choices when it comes to antibiotic therapy.

Gender

ALL

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)