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

STATUS

Recruiting
End date

Apr 28, 2024
participants needed

1084
sponsor

Rambam Health Care Campus

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Updated on 28 October 2021

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ceftriaxone

bacteremia

carbapenem

ceftazidime

meropenem

beta-lactam

cephalosporins

piperacillin-tazobactam

blood culture

lactam

beta-lactamase inhibitor

piperacillin

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.

Details

Condition	bacteraemia, Sepsis and Septicemia, Bacterial Infection, Enterobacteriaceae Infections, Septicemia, Bacterial Infections, blood poisoning, Beta Lactam Resistant Bacterial Infection, Bacteremia
Treatment	Meropenem, Piperacillin/Tazobactam
Clinical Study Identifier	NCT03671967
Sponsor	Rambam Health Care Campus
Last Modified on	28 October 2021

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Adults (age 18 years)
	New onset BSI due to E. coli or Klebsiella 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 E. coli or Klebsiella spp. with concomitant growth in blood of skin commensals considered as contaminants
Exclusion Criteria
	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>15g/kg/min, adrenalin>0.1g/kg/min, noradrenalin>0.1g/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)

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