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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520940-14-00
Enrollment
456
Registered
2025-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pyogenic liver abscess

Brief summary

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

Detailed description

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.

Interventions

DRUGLINEZOLID
DRUG-
DRUGDAPTOMYCIN
DRUGCOLISTIN
DRUGMETRONIDAZOLE
DRUGAMIKACIN
DRUGIMIPENEM

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 r

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026