Trial | NCT02681263  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    temocillin ...

  • Study Participants

    25
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.
Study Started
Apr 30
2016
Primary Completion
Apr 30
2018
Study Completion
Sep 30
2018
Anticipated
Last Update
Jun 06
2018

Drug Temocillin

Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy.

  • Other names: NEGABAN

Temocillin Experimental

Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy. Total antibiotic treatment between 10 and 14 days according to local guidelines (up to 21 days in immunosuppressed patients).

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
No Results Posted