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

Belpharma

Status and phase

Withdrawn

Phase 4

Conditions

Urinary Tract Infection

Treatments

Drug: Temocillin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01543347

2008-005912-41 (EudraCT Number)

TMO-07001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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