This study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection (UTI) due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom.
The spectrum of activity together with the route of excretion of temocillin makes it a good candidate for the treatment of urinary tract infections. Several studies have shown very good clinical and microbiological activity in uncomplicated and complicated cystitis and pyelonephritis in adults and in pyelonephritis in children older than 2 months. However there is no specific study performed on Urinary Tract Infections due to broad spectrum ß-lactamases producing strains. In this context, this study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection due to confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom. 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
Antibiotic treatment
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Microbiological cure
Eradication : \< 10,000 Colony forming Unit/mL (CFU/mL) of the baseline pathogen * Persistence : = 10,000 CFU/mL of the baseline pathogen * Persistence with acquisition of resistance * Superinfection : = 100,000 CFU/mL of another uropathogen during therapy * New infection : = 100,000 CFU/mL of another uropathogen after therapy * Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up * Relapse with acquisition of resistance
Time frame: End of treatment (minimum 5 days)
Clinical cure
Clinical status of the patient will be classified as * cured (resolution of all clinical symptoms) * improved * failure (persistence of baseline clinical symptoms or emergence of new symptoms)
Time frame: End of treatment (minimum 5 days)
Development of resistance during treatment
Acquisition of resistance to temocillin during treatment on a microbiological point of view
Time frame: End of treatment (minimum 5 days)
Infection relapses monitored over 4-6 weeks
* Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up * Relapse with acquisition of resistance
Time frame: End of follow-up (up to 6 weeks)
Monitoring of AE
Record of any untoward medical occurrence in a clinical trial patient administered temocillin and which does not necessarily have to have a causal relationship with the treatment.
Time frame: From day 0 to up to 6 weeks
ESBL & AmpC fecal carriage (optional)
All isolates of included patients will be kept frozen at -80°C and sent to the central laboratory for ESBL/AmpC confirmation and typing through molecular techniques. Pulse field gel electrophoresis will be performed on isolates from the same species for determination of clonality.
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Time frame: Start and end of treatment (minimum 5 days)
Incidence of C. difficile infection
Clostridium difficile infection (CDI) is defined as recommended by the HPA Steering Group on Healthcare Associated Infection 35 : one episode of diarrhoea, defined either as stool loose enough to take the shape of a container used to sample it, or as Bristol Stool Chart types 5-7, which is not attributable to any other cause including medicines which occurs at the same time as a positive toxin assay (with or without a positive C. difficile culture) and/or endoscopic evidence of pseudomembranous colitis.
Time frame: From day 0 to up to 6 weeks