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