Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae (TEMO-ESBL)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Unknown; Phase 4

Conditions: Urinary Tract Infections

Treatments: Drug: Temocillin

Study type: Interventional

Funder types: Other

Identifiers

NCT02681263

38RC15.213

2015-004178-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Temocillin

Experimental group

Description:

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).

Treatment:

Drug: Temocillin