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Temocillin Versus a Carbapenem as Initial Intravenous Treatment for Extended-spectrum Beta-lactamase Related Urinary Tract Infections, a Non-inferiority Study
TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.
Urinary tract infections are among the most common bacterial infections that are treated in the community by an empirical antibiotic treatment regimen. Enterobacteriaceae are the most common bacteria involved in urinary tract infection. Since 2006, extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae have spread in France, as elsewhere. Finding therapeutic alternatives to carbapenems in infections caused by ESBL producing enterobacteriaceae is imperative. Although temocillin, 6-α-methoxy derivative of ticarcillin has been suggested as a potential alternative to carbapenem therapy for ESBL related infections, it was not investigated in accordance with current standard. The hypothesis to test in this study is that temocillin is not inferior to a carbapenem as initial intravenous treatment of urinary tract infections caused by ESBL producing enterobacteriaceae.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHU de Martinique
Fort-de-france, Martinique, France
CHRU La Cavale Blanche
Brest, France
CHU de Grenoble Hospital
Grenoble, France
Melun Hospital - CHU Sud
Melun, France
APHP - Cochin Hospital
Paris, France
APHP - Necker-Enfants maladies Hospital
Paris, France
Bichat hospital
Paris, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, France
Tenon Hospital
Paris, France
APHP - Beaujon Hospital
Paris, France
Start Date
January 4, 2019
Primary Completion Date
October 29, 2020
Completion Date
December 14, 2020
Last Updated
November 20, 2025
29
ACTUAL participants
Temocillin
DRUG
meropenem or imipenem
DRUG
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
NCT05488340
NCT07233473
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03825874