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

NCT01543347 | Withdrawn Phase 4

• 2 other identifiers: TMO-070012008-005912-41
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection

Keywords

UTI; ESBL; AmpC Enterobacteriaceae

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Clinical cure

  End of treatment (minimum 5 days)

• Development of resistance during treatment

  End of treatment (minimum 5 days)

• Infection relapses monitored over 4-6 weeks

  End of follow-up (up to 6 weeks)

• Monitoring of AE

  From day 0 to up to 6 weeks

• ESBL & AmpC fecal carriage (optional)

  Start and end of treatment (minimum 5 days)

Study Arms (1)

Temocillin

EXPERIMENTAL

Treatment group

Drug: Temocillin

Interventions

Temocillin DRUG

Antibiotic treatment

Also known as: Negaban

Temocillin

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Belpharma s.a.: lead

Study Sites (1)

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

temocillin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Peter M Hawkey, Professor

  Birmingham Public Health Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: March 5, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

GB (1)