Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL)/AmpC Enterobacteriaceae

• Status: Withdrawn
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belpharma s.a.
• Treatments: Penicillins; Temocillin

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