Piperacillin/tazobactam
Drug4.5 grams QID
NCT Number: NCT03671967
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
University of Calgary, Cumming School of Medicine, O'Brien Institute for Public Health, Calgary, Alberta, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4.5 grams QID
1 gram TID
Time frame: 30 days from randomization
Time frame: 7 days from randomization
death OR fever > 38°C in the last 48 hours OR lack of resolution of symptoms attributed to the focus of infection OR Sequential Failure Organ Assessment (SOFA) score increasing OR positive blood cultures by the time point assessed
Time frame: 14 and 90 days from randomization
Time frame: 14 days and 30 days from randomization
death OR fever > 38°C in the last 48 hours OR lack of resolution of symptoms attributed to the focus of infection OR Sequential Failure Organ Assessment (SOFA) score increasing OR positive blood cultures by the time point assessed
Time frame: 7 days and 14 days from randomization
Repeat positive blood cultures with index pathogen on day 4 or later from randomization
Time frame: 30 days and 90 days from randomization
recurrent positive blood cultures with the index pathogen after prior sterilization of blood cultures or after end of treatment
Time frame: 90 days from randomization
Time frame: 90 days from randomization
Time frame: 90 days from randomization
Time frame: 90 days from randomization
clinical isolates resistant to piperacillin/tazobactam and meropenem and any carbapenem-resistant bacteria
Time frame: 90 days from randomization
detected by weekly rectal surveillance of carriage while in-hospital
Time frame: 30 days and 90 days from randomization
Time frame: 30 days and 90 days from randomization
Time frame: 30 days from randomization
diarrhea, liver function test abnormalities, antibiotic rash or other immediate-type allergy, acute kidney injury defined according to RIFLE criteria
Contact information is provided by the study sponsor or research team.
Mical Paul, MD
CONTACT
Roni Bitterman, MD
CONTACT
Rambam Health Care Campus
Other
Piperacillin Tazobactam Versus Meropenem for Treatment of Bloodstream Infections Caused by Cephalosporin-resistant Enterobacteriaceae- a Non-inferiority Randomized Controlled Trial
Acronym: PETERPEN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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