search
Back to results

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

Primary Purpose

Urinary Tract Infection

Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Temocillin
Sponsored by
Belpharma s.a.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring UTI, ESBL, AmpC Enterobacteriaceae

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Birmingham Heartlands Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temocillin

Arm Description

Treatment group

Outcomes

Primary Outcome Measures

Microbiological cure
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
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
Acquisition of resistance to temocillin during treatment on a microbiological point of view
Infection relapses monitored over 4-6 weeks
Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up Relapse with acquisition of resistance
Monitoring of AE
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)
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
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.

Full Information

First Posted
February 22, 2012
Last Updated
January 28, 2013
Sponsor
Belpharma s.a.
search

1. Study Identification

Unique Protocol Identification Number
NCT01543347
Brief Title
Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL)/AmpC Enterobacteriaceae
Acronym
TEA
Official Title
Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases (ESBL) Producing and AmpC Hyperproducing Enterobacteriaceae in United Kingdom
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Withdrawn
Why Stopped
No patient has been included in 9 months because of strict incl/excl criteria
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belpharma s.a.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
UTI, ESBL, AmpC Enterobacteriaceae

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Temocillin
Arm Type
Experimental
Arm Description
Treatment group
Intervention Type
Drug
Intervention Name(s)
Temocillin
Other Intervention Name(s)
Negaban
Intervention Description
Antibiotic treatment
Primary Outcome Measure Information:
Title
Microbiological cure
Description
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
Time Frame
End of treatment (minimum 5 days)
Secondary Outcome Measure Information:
Title
Clinical cure
Description
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)
Time Frame
End of treatment (minimum 5 days)
Title
Development of resistance during treatment
Description
Acquisition of resistance to temocillin during treatment on a microbiological point of view
Time Frame
End of treatment (minimum 5 days)
Title
Infection relapses monitored over 4-6 weeks
Description
Relapse : eradication at end of treatment but = 10,000 CFU/mL of the baseline pathogen at follow up Relapse with acquisition of resistance
Time Frame
End of follow-up (up to 6 weeks)
Title
Monitoring of AE
Description
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.
Time Frame
From day 0 to up to 6 weeks
Title
ESBL & AmpC fecal carriage (optional)
Description
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.
Time Frame
Start and end of treatment (minimum 5 days)
Title
Incidence of C. difficile infection
Description
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.
Time Frame
From day 0 to up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Hawkey, Professor
Organizational Affiliation
Birmingham Public Health Laboratory
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs