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

January 28, 2013 updated by: Belpharma s.a.

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • Birmingham Heartlands Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temocillin
Treatment group
Drug: Temocillin
Antibiotic treatment
Other Names:
  • Negaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological cure
Time Frame: End of treatment (minimum 5 days)

Eradication : < 10,000 Colony forming Unit/mL (CFU/mL) of the baseline pathogen

  • Persistence : = 10,000 CFU/mL of the baseline pathogen
  • Persistence with acquisition of resistance
  • Superinfection : = 100,000 CFU/mL of another uropathogen during therapy
  • New infection : = 100,000 CFU/mL of another uropathogen after therapy
  • Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up
  • Relapse with acquisition of resistance
End of treatment (minimum 5 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical cure
Time Frame: End of treatment (minimum 5 days)

Clinical status of the patient will be classified as

  • cured (resolution of all clinical symptoms)
  • improved
  • failure (persistence of baseline clinical symptoms or emergence of new symptoms)
End of treatment (minimum 5 days)
Development of resistance during treatment
Time Frame: End of treatment (minimum 5 days)
Acquisition of resistance to temocillin during treatment on a microbiological point of view
End of treatment (minimum 5 days)
Infection relapses monitored over 4-6 weeks
Time Frame: End of follow-up (up to 6 weeks)
  • Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up
  • Relapse with acquisition of resistance
End of follow-up (up to 6 weeks)
Monitoring of AE
Time Frame: From day 0 to up to 6 weeks
Record of any untoward medical occurrence in a clinical trial patient administered temocillin and which does not necessarily have to have a causal relationship with the treatment.
From day 0 to up to 6 weeks
ESBL & AmpC fecal carriage (optional)
Time Frame: Start and end of treatment (minimum 5 days)
All isolates of included patients will be kept frozen at -80°C and sent to the central laboratory for ESBL/AmpC confirmation and typing through molecular techniques. Pulse field gel electrophoresis will be performed on isolates from the same species for determination of clonality.
Start and end of treatment (minimum 5 days)
Incidence of C. difficile infection
Time Frame: From day 0 to up to 6 weeks
Clostridium difficile infection (CDI) is defined as recommended by the HPA Steering Group on Healthcare Associated Infection 35 : one episode of diarrhoea, defined either as stool loose enough to take the shape of a container used to sample it, or as Bristol Stool Chart types 5-7, which is not attributable to any other cause including medicines which occurs at the same time as a positive toxin assay (with or without a positive C. difficile culture) and/or endoscopic evidence of pseudomembranous colitis.
From day 0 to up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belpharma s.a.

Investigators

  • Principal Investigator: Peter M Hawkey, Professor, Birmingham Public Health Laboratory

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMO-07001
  • 2008-005912-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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