PipEracillin Tazobactam versus mERoPENem for treatment of bloodstream infections caused by cephalosporin-resistant Enterobacteriaceae - a non-inferiority randomized controlled trial (PETERPEN)
EU CTIS ID: 2024-518583-13-00
What this study is testing
To evaluate the effect of definitive treatment with meropenem vs. PTZ on the outcome of patients with bacteremia due to third-generation cephalosporin-non-susceptible (but PTZ susceptible) E. coli, K. pneumoniae or other Klebsiella spp. (assumed ESBL-E), and SPICE-M organisms: Serratia marcescens, Providencia spp., Morganella morganii, Citrobacter freundii, and Enterobacter spp. We aim to prove the hypothesis that PTZ is non-inferior to meropenem.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Adults (age ≥ 18 years) 2. New onset BSI due to E. coli,Klebsiella spp., Serratia marcescens, Providencia spp., Morganella morganii, Citrobacter freundii, and Enterobacter 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 study pathogens with concomitant growth in blood of skin commensals considered as contaminants.
You likely can't join if
- 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: a. Endocarditis / endovascular infections b. Osteomyelitis (not resected) c. 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) or patient in palliative care
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.