Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study will describe and support the use of high dose (6g/day) of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborator: French National Network of Clinical Research in Infectious Diseases (RENARCI)
• Treatments: Penicillins; Temocillin

Criteria

Inclusion Criteria:

• Age of at least 18 year old

• Patient benefits from social security

• Signed informed consent

• A urinary tract infection due to a confirmed ESBL producing strain (detected by the use of a rapid diagnostic test applied on the urine) requiring parenteral antimicrobial therapy

• Hospitalized patient

• For women able to procreate: Use of an acceptable method of birth control throughout the study. Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide and condom. (All forms of hormonal contraception are acceptable

Exclusion Criteria:

• Patient infected with a bacteria which is not an ESBL-producing or AmpC hyperproducing Enterobacteriaceae

• Patients infected with a strain sensible to both fluoroquinolones and trimethoprim/sulfamethoxazole

• Patients infected with a strain resistant to temocillin

• Hospital-acquired urinary tract infection (defined as a urinary infection that occurred at least 48h post admission in the hospital)

• Patients has received any dose of active antimicrobial therapy (an antibiotic to which the infecting bacterium is susceptible) in the last 48h (prior to enrolment) except ≤ 2 dose of gentamicin.

• Patients presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin) due to Gram negative bacteria.

• Patients needing concomitant antimicrobial therapy.

• Septic shock

• Children (up to 18 years old)

• Women who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause)

• Patients with any kind of urinary/bladder catheter (JJ ureteral probe, …)

• Hypersensitivity to the active substance, to penicillins or to any other type of beta-lactam agent

• Chronically dialyzed patients

• Patients having a creatinine clearance < 30 mL/min

• Complete obstruction of the urinary tract

• Perinephretic or intrarenal abscesses

• Tutorship or curatorship patient

• Patient unable to give his consent