Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL) Producing and AmpC Hyperproducing Enterobacteriaceae in United Kingdom
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Belpharma s.a.
- Locations
- 1
- Primary Endpoint
- Microbiological cure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Temocillin
Treatment group
Intervention: Temocillin (Drug)
Outcomes
Primary Outcomes
Microbiological cure
Time Frame: 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 Outcomes
- Clinical cure(End of treatment (minimum 5 days))
- Development of resistance during treatment(End of treatment (minimum 5 days))
- Infection relapses monitored over 4-6 weeks(End of follow-up (up to 6 weeks))
- Monitoring of AE(From day 0 to up to 6 weeks)
- ESBL & AmpC fecal carriage (optional)(Start and end of treatment (minimum 5 days))
- Incidence of C. difficile infection(From day 0 to up to 6 weeks)