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

Urinary Tract Infection Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01543347
• Other study ID #: TMO-07001
• Secondary ID: 2008-005912-41
• Status: Withdrawn
• Phase: Phase 4
• First received: February 22, 2012
• Last updated: January 28, 2013
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2013
• Source: Belpharma s.a.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyEuropean Union: European Medicines AgencyBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Temocillin
Antibiotic treatment

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Belpharma s.a.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	End of treatment (minimum 5 days)	No
Secondary	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)	End of treatment (minimum 5 days)	No
Secondary	Development of resistance during treatment	Acquisition of resistance to temocillin during treatment on a microbiological point of view	End of treatment (minimum 5 days)	No
Secondary	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	End of follow-up (up to 6 weeks)	No
Secondary	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.	From day 0 to up to 6 weeks	Yes
Secondary	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.	Start and end of treatment (minimum 5 days)	No
Secondary	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.	From day 0 to up to 6 weeks	Yes