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

This study has been withdrawn prior to enrollment.
(No patient has been included in 9 months because of strict incl/excl criteria)
Sponsor:
Information provided by (Responsible Party):
Belpharma s.a.
ClinicalTrials.gov Identifier:
NCT01543347
First received: February 22, 2012
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
Drug: Temocillin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL) Producing and AmpC Hyperproducing Enterobacteriaceae in United Kingdom

Resource links provided by NLM:


Further study details as provided by Belpharma s.a.:

Primary Outcome Measures:
  • Microbiological cure [ Time Frame: End of treatment (minimum 5 days) ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Clinical cure [ Time Frame: End of treatment (minimum 5 days) ] [ Designated as safety issue: No ]

    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)

  • Development of resistance during treatment [ Time Frame: End of treatment (minimum 5 days) ] [ Designated as safety issue: No ]
    Acquisition of resistance to temocillin during treatment on a microbiological point of view

  • Infection relapses monitored over 4-6 weeks [ Time Frame: End of follow-up (up to 6 weeks) ] [ Designated as safety issue: No ]
    • Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up
    • Relapse with acquisition of resistance

  • Monitoring of AE [ Time Frame: From day 0 to up to 6 weeks ] [ Designated as safety issue: Yes ]
    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.

  • ESBL & AmpC fecal carriage (optional) [ Time Frame: Start and end of treatment (minimum 5 days) ] [ Designated as safety issue: No ]
    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.

  • Incidence of C. difficile infection [ Time Frame: From day 0 to up to 6 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 0
Study Start Date: February 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Temocillin
Treatment group
Drug: Temocillin
Antibiotic treatment
Other Name: Negaban

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543347

Locations
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Sponsors and Collaborators
Belpharma s.a.
Investigators
Principal Investigator: Peter M Hawkey, Professor Birmingham Public Health Laboratory
  More Information

No publications provided

Responsible Party: Belpharma s.a.
ClinicalTrials.gov Identifier: NCT01543347     History of Changes
Other Study ID Numbers: TMO-07001, 2008-005912-41
Study First Received: February 22, 2012
Last Updated: January 28, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
European Union: European Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Belpharma s.a.:
UTI
ESBL
AmpC Enterobacteriaceae

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Temocillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014