A

Phase 1

Active, not recruiting

• Conditions: MedDRA version: 20.0Level: PTClassification code 10054088Term: Urinary tract infection bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; -Hospitalized patient with complicated UTI due to ESBL producing enterobacteriaceae (pyelonephritis, prostatitis or renal abscess) requiring parenteral antimicrobial therapy.

• Registration Number: EUCTR2017-001257-14-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-20
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

- Adult (> or = 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 in fertile women 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
- Patient affiliated to the social security system
(*) UTI was defined according the SPILF guidelines [20] as pyuria (white blood cell count greater than 104/mL in urine) associated with clinical symptoms of urinary tract infection.
(**) Only complicated urinary tract infections (Pyelonephritis, prostatitis and renal abcess) will be included. Cystitis will be excluded.
Bacteriuria was defined as a bacterial culture > 103 UFC/mL.
(***) Susceptibility to temocillin and carbapenems will be determined according to CA-SFM 2015 guidelines.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Patient infected with a bacteria which is not an ESBL-producing enterobacteriacae.
- Patient infected with a strain resistant to temocillin.
- Polymicrobial infection.
- Hypersensitivity and/or previous intolerance to carbapenem or temocillin or penicillins or any other beta-lactam.
- 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 expectance < 90 days.
- Ongoing empirical treatment of the urinary tract infections with carbapenem.
- Delay in randomization > 24 hours after identification of ESBL producing enterobacteriacaeae in urinary and/or blood culture.
- Participation in other clinical trial for the infection.
- Patient under tutorship or curatorship.
- Patient unable to give consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified