Status:
WITHDRAWN
PipEracillin/Tazobactam Versus mERoPENem for Treatment of AmpC Producing Blood Stream Infections
Lead Sponsor:
Rambam Health Care Campus
Collaborating Sponsors:
The Chaim Sheba Medical Center
Rabin Medical Center
Conditions:
Beta Lactam Resistant Bacterial Infection
Enterobacteriaceae Infections
Eligibility:
All Genders
18-120 years
Phase:
PHASE4
Brief Summary
Data regarding optimal treatment for extended-spectrum beta-lactamase (ESBL) producing Enterobacterales bloodstream infection are lacking. Observational studies show conflicting results when comparing...
Detailed Description
PeterPen-SPICE-M will expland the PeterPen trial. In PeterPen we recruit patients with bacteremia caused by 3rd generation cephalosporin-resistant E. coli or Klebsiella pneumoniae. In SPICE-M we will ...
Eligibility Criteria
Inclusion
- Adults (age ≥ 18 years)
- New onset BSI due to Serratia marcescens, Providencia spp., Morganella morganii, Citrobacter freundii, and Enterobacter spp.in one or more blood cultures associated with evidence of infection.
- 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).
- Both community and hospital-acquired bacteremias will be included.
- We will permit the inclusion of bacteremias due to study pathogens with concomitant growth in blood of skin commensals considered as contaminants.
Exclusion
- More than 72 hr. elapsed since initial blood culture taken, regardless of the time covering antibiotics were started (up to 72 hrs.).
- 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.
- Patients with prior bacteremia or infection that have not completed antimicrobial therapy for the previous infectious episode.
- 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.
- BSI due to specific infections known at the time of randomization:
- Endocarditis / endovascular infections
- Osteomyelitis (not resected)
- Central nervous system infections
- Allergy to any of the study drugs confirmed by history taken by the investigator
- Previous enrollment in this trial
- Concurrent participation in another interventional clinical trial
- Imminent death (researcher's assessment of expected death within 48 hrs. of recruitment) or patient in palliative care
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05355350
Start Date
July 1 2022
End Date
July 21 2025
Last Update
July 24 2025
Active Locations (4)
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1
Rambam Health Care Campus
Haifa, Israel
2
Hadassah Medical Center
Jerusalem, Israel
3
Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel
4
Sheba Tel HaShomer Medical Campus
Ramat Gan, Israel