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

Sponsors

Lead Sponsor: Belpharma s.a.

Source Belpharma s.a.
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.

Overall Status Withdrawn
Start Date 2012-02-01
Completion Date 2012-11-01
Primary Completion Date 2012-11-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Microbiological cure End of treatment (minimum 5 days)
Secondary Outcome
Measure Time Frame
Clinical cure End of treatment (minimum 5 days)
Development of resistance during treatment End of treatment (minimum 5 days)
Infection relapses monitored over 4-6 weeks End of follow-up (up to 6 weeks)
Monitoring of AE From day 0 to up to 6 weeks
ESBL & AmpC fecal carriage (optional) Start and end of treatment (minimum 5 days)
Incidence of C. difficile infection From day 0 to up to 6 weeks
Condition
Intervention

Intervention Type: Drug

Intervention Name: Temocillin

Description: Antibiotic treatment

Arm Group Label: Temocillin

Other Name: 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

Gender:

All

Minimum Age:

21 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Peter M Hawkey, Professor Principal Investigator Birmingham Public Health Laboratory
Location
Facility: Birmingham Heartlands Hospital
Location Countries

United Kingdom

Verification Date

2013-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Temocillin

Type: Experimental

Description: Treatment group

Acronym TEA
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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