Urinary Tract Infection
Conditions
Keywords
UTI, ESBL, AmpC Enterobacteriaceae
Brief summary
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.
Detailed description
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.
Interventions
DRUGTemocillin
Antibiotic treatment
Sponsors
Belpharma s.a.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients presenting a complicated urinary tract infection due to a confirmed Extended Spectrum Beta-Lactamases (ESBL) producing or AmpC hyperproducing Enterobacteriaceae susceptible to temocillin requiring parenteral antimicrobial therapy. * community or hospital acquired infecting bacteria. * signed informed consent
Exclusion criteria
* patients infected with a strain resistant to temocillin * patients having received an active antimicrobial therapy during the 48h before the beginning of temocillin treatment except temocillin * patients presenting another site of infection than urinary (except onset of bacteremia from urinary tract origin) due to Gram negative bacteria * patients needing concomitant antimicrobial therapy with the exception of benzylpenicillin * uncomplicated cystitis * complete obstruction of the urinary tract * prostatitis * peri-nephretic or intrarenal abscesses * renal transplant * children (up to 18 years old) * pregnancy or lactation * chronically dialyzed patients * immunocompromising therapy or illness * known allergy to penicillin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological cure | End of treatment (minimum 5 days) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of resistance during treatment | End of treatment (minimum 5 days) | Acquisition of resistance to temocillin during treatment on a microbiological point of view |
| Infection relapses monitored over 4-6 weeks | End of follow-up (up to 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 |
| Clinical cure | End of treatment (minimum 5 days) | 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) |
| ESBL & AmpC fecal carriage (optional) | Start and end of treatment (minimum 5 days) | 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. |
| Incidence of C. difficile infection | From day 0 to up to 6 weeks | 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. |
| Monitoring of AE | From day 0 to up to 6 weeks | 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. |
Countries
United Kingdom
Outcome results
None listed