Clinical trial NCT01543347: Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL)/AmpC Enterobacteriaceae
Official title: Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL) Producing and AmpC Hyperproducing Enterobacteriaceae in United Kingdom
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Urinary Tract Infection
Keywords: UTI
ESBL
AmpC Enterobacteriaceae
Lead sponsor: Belpharma s.a.
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbiological cure
timeFrame: End of treatment (minimum 5 days)
Secondary outcomes:
measure: Clinical cure
timeFrame: End of treatment (minimum 5 days)
measure: Development of resistance during treatment
timeFrame: End of treatment (minimum 5 days)
measure: Infection relapses monitored over 4-6 weeks
timeFrame: End of follow-up (up to 6 weeks)
measure: Monitoring of AE
timeFrame: From day 0 to up to 6 weeks
measure: ESBL & AmpC fecal carriage (optional)
timeFrame: Start and end of treatment (minimum 5 days)
measure: Incidence of C. difficile infection
timeFrame: From day 0 to up to 6 weeks
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
Study officials:
affiliation: Birmingham Public Health Laboratory
name: Peter M Hawkey, Professor
role: PRINCIPAL_INVESTIGATOR
References: