The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study will describe and support the use of high dose (6g/day) of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy.
CH Ajaccio
Ajaccio, France
CH Annecy Genevois
Annecy, France
APHP - Avicenne Hospital
Bobigny, France
APHP - Beaujon Hospital
Clichy, France
CHU de Martinique
Fort de France, France
CHU de Grenoble
Grenoble, France
APHP - Bicêtre Hospital
Le Kremlin-Bicêtre, France
CHU de Lille
Lille, France
CHU de Nantes
Nantes, France
CHU de Nice
Nice, France
...and 9 more locations
Microbiological efficacy at Test of Cure in patients microbiologically evaluable
The microbiological efficacy will be assessed by quantitative urine culture and defined as follows: * Eradication : \< 10\^3 CFU/mL of the baseline pathogen * Persistence : ≥ 10\^3 CFU/ml of the baseline pathogen * Superinfection : ≥ 10\^5 CFU/ml of another uropathogen during therapy * New infection : ≥ 10\^5 CFU/ml of another uropathogen after therapy * Relapse : eradication at TOC but ≥ 10\^3 CFU/mL of the baseline pathogen at FU Overall microbiological response will be determined as "unfavorable" if persistence or superinfection or new infection or relapse.
Time frame: 7 days post end of Temocillin Treatment
Clinical efficacy in clinical evaluable group
Each patient's response will be categorized as cure (resolution of all clinical symptoms), improvement (normalization of body temperature but persistence of either urinary syndrome or flank pain) or failure (persistence of baseline clinical symptoms or emergence of new symptoms related to UTI).
Time frame: 3 weeks for end of Temocillin Treatment
Microbiological efficacy
The microbiological efficacy will be assessed by quantitative urine culture and defined as follows: * Eradication : \< 10\^3 CFU/mL of the baseline pathogen * Persistence : ≥ 10\^3 CFU/ml of the baseline pathogen * Superinfection : ≥ 10\^5 CFU/ml of another uropathogen during therapy * New infection : ≥ 10\^5 CFU/ml of another uropathogen after therapy * Relapse : eradication at TOC but ≥ 10\^3 CFU/mL of the baseline pathogen at FU
Time frame: 3 weeks for end of Temocillin Treatment
Development of resistance to temocillin during treatment
The acquisition of resistance will be monitored in the central laboratory and is defined as an increase in MIC of at least 4 dilutions.
Time frame: 3 weeks for end of Temocillin Treatment
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