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

NCT ID: NCT01543347

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-11-30

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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temocillin

Treatment group

Group Type: EXPERIMENTAL

Temocillin

Intervention Type: DRUG

Antibiotic treatment

Interventions

Temocillin

Antibiotic treatment

Intervention Type: DRUG

Other Intervention Names

Negaban

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belpharma s.a.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter M Hawkey, Professor

Role: PRINCIPAL_INVESTIGATOR

Birmingham Public Health Laboratory

Locations

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2008-005912-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TMO-07001

Identifier Type: -

Identifier Source: org_study_id