Trial | NCT01543347  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    temocillin ...

  • Study Participants

    0
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 Started
Feb 29
2012
Primary Completion
Nov 30
2012
Study Completion
Nov 30
2012
Last Update
Jan 29
2013
Estimate

Drug Temocillin

Antibiotic treatment

  • Other names: Negaban

Temocillin Experimental

Treatment group

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
No Results Posted