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

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Feb 9, 2016

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Gender

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Eligibility 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