Temocillin use in Complicated Urinary Tract Infections due to ESBL producing and AmpC hyperproducing Enterobacteriaceae in United Kingdom - TEA trial

Phase 1

• Conditions: Patients presenting urinary tract infections due to Extended Spectrum Beta-Lactamases producing or AmpC hyperproducing Enterobacteriaceae.; MedDRA version: 9.1Level: LLTClassification code 10046571Term: Urinary tract infection; MedDRA version: 9.1Level: LLTClassification code 10002737Term: Antibiotic resistant strain

• Registration Number: EUCTR2008-005912-41-GB
• Lead Sponsor: Belpharma SA/NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-31
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patient presenting a complicated urinary tract infection (i.e. acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign bodies, or urologic abnormalities) due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae susceptible to temocillin requiring parenteral antimicrobial therapy
• community or hospital acquired infecting bacteria
• signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• patients infected with a strain resistant to temocillin (if included at first, then the patient will be kept in the ITT group, therapy will be switched and the patient will be followed for the same time as other enrolled patients).
• patients having received an active antimicrobial therapy during the 48h before the beginning of temocillin treatment (i.e. having received an antibiotic to which the infecting bacteria is susceptible) except temocillin (i.e. if the patient has been treated empirically with temocillin, they will not be excluded)
• patients presenting with 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
• perinephretic 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified