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

Sponsor

Belpharma s.a. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01543347

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection	Drug: Temocillin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Temocillin

Treatment group

Drug: Temocillin

Antibiotic treatment

Other Names:

Negaban

Outcome Measures

Primary Outcome Measures

Microbiological cure [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

Secondary Outcome Measures

Clinical cure [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)
Development of resistance during treatment [End of treatment (minimum 5 days)]
Acquisition of resistance to temocillin during treatment on a microbiological point of view
Infection relapses monitored over 4-6 weeks [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
Monitoring of AE [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.
ESBL & AmpC fecal carriage (optional) [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.
Incidence of C. difficile infection [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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