Informations générales (source: ClinicalTrials.gov)
Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae (TEMO-ESBL)
Interventional
Phase 4
University Hospital, Grenoble (Voir sur ClinicalTrials)
avril 2016
septembre 2018
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Beaujon | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Bichat | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP - Bicêtre Hospital - Kremlin-Bicêtre - France | Contact (sur clinicalTrials) | ||||
| APHP - St Louis - Paris - France | Contact (sur clinicalTrials) | ||||
| CH Ajaccio - Ajaccio - France | Contact (sur clinicalTrials) | ||||
| CH Annecy Genevois - Annecy - France | Contact (sur clinicalTrials) | ||||
| CH de Perpignan - Perpignan - France | Contact (sur clinicalTrials) | ||||
| CHU de Grenoble - Grenoble - France | Contact (sur clinicalTrials) | ||||
| CHU de Lille - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU de Martinique - Fort De France - France | Contact (sur clinicalTrials) | ||||
| CHU de Nantes - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHU de Nice - Nice - France | Contact (sur clinicalTrials) | ||||
| CHU de Pointe à Pitre - Pointe À Pitre - France | Contact (sur clinicalTrials) | ||||
| CHU de Poitiers - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHU de Rouen - Rouen - France | Contact (sur clinicalTrials) | ||||
| CHU de Saint Etienne - Saint Etienne - France | Contact (sur clinicalTrials) | ||||
| CHU de Tours - Tours - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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