A Phase 3 interventional study of Temocillin and meropenem or imipenem in Urinary Tract Infections, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
This study's enrollment of 29 is below the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Intravenous temocillin 2g/intravenously/8h or renally adjusted equivalent (ORAE) in 30-40 min infusion or continuous intravenous (6g/24h)
Drug: Temocillin
Intravenous meropenem or imipenem 1g/Intravenously /8h ORAE in 15-30 min infusion. Then switch to oral therapy
Drug: meropenem or imipenem
Intravenous temocillin disodium 2g intravenously/8h Or Renally Adjusted Equivalent (ORAE) in 30-40 min infusion or continuous intravenous (6g/24h) .
Intravenous carbapenem (meropenem 1g intravenously/8h Or Renally Adjusted Equivalent (ORAE) or imipenem 1g intravenously/8h ORAE)
Also known as: Carbapenems
Clinical and microbiological cure
The primary endpoint, was defined as achieving both clinical cure and microbiological eradication of all baseline pathogens 5-7 days after completion of treatment. Clinical cure is defined as complete resolution, substantial improvement or return to pre-infections signs and symptoms of complicated lower urinary tract infections or pyelonephritis without the need for additional antibiotic therapy Microbiological efficacy will be assessed by quantitative urine culture and defined as follows \< 10\^3 Colony Forming Unit (CFU)/mL of the baseline pathogens
Time frame: 5-7 days after end of treatment
Early microbiological eradication
Microbiological eradication will be assessed by quantitative urine culture and defined as follows \< 10\^3 colony forming unit Colony Forming Unit (CFU)/mL of the baseline pathogens
Time frame: 3-4 days after randomization
Frequency of oral antibiotic switch in both arms (temocillin vs. carbapenem)
Time frame: 60 days after randomization
Length of hospital stay
Time from randomization to hospital discharge
Time frame: 60 days after randomization
Persistent cure rate
Clinical cure is defined as complete resolution, substantial improvement or return to pre-infections signs and symptoms of complicated lower urinary tract infections or pyelonephritis without the need for additional antibiotic therapy
Time frame: 60 days after randomization
Clinical recurrences
Relapse: new symptoms of urinary tract infection in a patient previously considered as clinically or microbiologically cured in the visit 5-7 days after treatment completion plus positive urine ± blood culture grows the same microorganism isolated that in the initial culture. Re-infection: same definition but with different strain in urinary culture
Time frame: 60 days after randomization
Mortality
Death for any reason or for infectious events
Time frame: 60 days after randomization
Pharmacokinetic of temocillin according to kidney function
Description of the temocillin plasma concentration and its variability among patients
Time frame: 3 days after treatment initiation
Microbiota impact study
Study treatment impact in the gut colonization with multidrug Gram negative bacilli) and temocillin resistant Gram negative bacilli
Time frame: Time Frame : 5-7 days after treatment completion
Plan to share: No
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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris