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Clinical Trials in the EU / 2025-520940-14-00
Authorised Phase IV

TIME-TO-LIA : Optimal Duration of Antibiotic Therapy in Drained Pyogenic Liver Abscess: 3 weeks versus 6 weeks, a non-inferiority trial

2025-520940-14-00 · tracked via the Priya Life Science EU tracker
Sponsor
Assistance Publique Hopitaux De Paris
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Bacterial Infections and Mycoses
Decision date
06/10/2025
Enrollment target
456
Sites
France

Condition studied

Pyogenic liver abscess

Investigational medicinal product(s)

MEROPENEM AND VABORBACTAMLINEZOLIDTEDIZOLIDSULFAMETHOXAZOLE AND TRIMETHOPRIM-CEFTAZIDIME AND BETA-LACTAMASE INHIBITOR-DAPTOMYCIN-COLISTIN-METRONIDAZOLEAMIKACINIMIPENEMCILASTATIN AND RELEBACTAM

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Proportion of patients with a treatment failure between the end of treatment and week 12 after the drainage of the abscess(es).

Endpoint detail

1. Time to death of any cause, 2. Proportion of patients with digestive colonization of MDRB at inclusion and at week 12 after drainage, assessed by rectal swabs., 3. Proportion of participants with treatment failure at the end of the ATB assigned by randomization., 4. Proportion of participants with complete regression of liver abscess(es) images at week 3, week 6, and week 12 after drainage., 5. Time to hospital discharge, 6. Intercurring events between week 12 and month 6 in each group (e.g. relapse of index infection, new liver abscess(es), death from any cause), 7. Clinical, anatomical, and microbiological characteristics of the PLA. Clinical, biological and treatment characteristics of the patients., 8. Characteristics and modalities of the antibiotic therapy administered to the participant (molecules, modalities, duration)., 9. Proportion of patients with an extended ATB longer than the duration assigned by the randomisation., 10. Proportion of patients with an appropriate ATB related to the bacterial documentation (intravenous and oral)., 11. Incidence of adverse events and serious adverse events.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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