Temocillin Versus a Carbapenem as Initial Intravenous Treatment for ESBL Related Urinary Tract Infections

• Status: Completed
• Trial end date: 2020-12-14
• Target enrollment: 0
• Participant gender: All

Summary

TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: French National Network of Clinical Research in Infectious Diseases (RENARCI); Groupe Hospitalier Paris Saint Joseph
• Treatments: Imipenem; Meropenem; Penicillins; Temocillin; Thienamycins

Criteria

Inclusion Criteria:

• Adult (≥ 18 years)

• Hospitalized patient with clinically significant monomicrobial UTI

• Complicated UTI due to ESBL producing enterobacteriaceae (pyelonephritis, prostatitis or renal abscess) requiring parenteral antimicrobial therapy

• Susceptibility to temocillin and carbapenem as evidenced by testing results

• For woman able to procreate: negative pregnancy test and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom). All forms of hormonal contraception are acceptable

• Signed informed consent by patient himself (able or under curatorship) or his legal representative (patient unable to give his consent or under tutorship)

• Patient affiliated to the social security system

Exclusion Criteria:

• Patient infected with a bacteria which is not an ESBL-producing enterobacteriaceae.

• Polymicrobial infection.

• Hypersensitivity and/or previous intolerance to carbapenem or temocillin, or penicillins or any other beta-lactam.

• Patient with a contraindication to any of the drugs to be used in research

• Patient presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin due to Gram negative bacteria).

• Woman who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause).

• Palliative care of life expectancy < 90 days.

• Ongoing empirical treatment of the urinary tract infections with carbapenem or temocillin > 24 hours before randomization

• Delay in randomization > 48 hours after identification of ESBL producing enterobacteriaceae in urinary and/or blood culture.

• Participation in other clinical trial for the infection.