MEROPENEM for Pyogenic liver abscess

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years old\n- Intra-hepatic abscess assessed by radiological evaluation (CT)\n- Bacterial confirmation by culture of pus extracted from liver abscess\n- Success of drainage (percutaneous drainage or aspiration by punction) defined by regression > 50 % of the size of the abscess on liver ultrasonography or CT at day 10 after +/- 2 days PLA drainage compared to the abscess size on CT performed before drainage."}

Exclusion criteria

• {"criterion_text":"- Non pyogenic bacterial aetiology of PLA: fungal, parasitic, mycobacterial, or absence of documentation\n- Patient under guardianship or trusteeship\n- Subject already involved in another interventional clinical research evaluating a medicinal product\n- Subject already involved in another interventional clinical research evaluating an interventional procedure for PLA treatment\n- Extra-hepatic abscess or infection in another site for which the duration of ATB would be longer than 3 weeks.\n- PLA occurring after liver transplantation or in a liver recipient patient.\n- Ischemic cholangitis as aetiology of PLA\n- Associated other(s) liver abcess(es) > 3 cm with no drainage possible\n- Contraindications to investigational medicinal products\n- Pregnant / breastfeeding women\n- Non-affiliation to a social security regimen or CMU\n- Patient refusal to participate or no possibility to give consent"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with a treatment failure between the end of treatment and week 12 after the drainage of the abscess(es).","definition_or_measurement_approach":"Measured as the proportion of patients with a treatment failure occurring between end of treatment and week 12 after drainage of the abscess(es) (as stated in the endpoint description)."}

Secondary endpoints

• {"endpoint_text":"- 1.\tTime to death of any cause","definition_or_measurement_approach":"Time-to-event (time from randomisation or index date to death of any cause)."}
• {"endpoint_text":"- 2.\tProportion of patients with digestive colonization of MDRB at inclusion and at week 12 after drainage, assessed by rectal swabs.","definition_or_measurement_approach":"Assessed by rectal swabs at inclusion and at week 12 to determine digestive colonization by multidrug-resistant bacteria (MDRB)."}
• {"endpoint_text":"- 3.\tProportion of participants with treatment failure at the end of the ATB assigned by randomization.","definition_or_measurement_approach":"Measured as proportion of participants meeting criteria for treatment failure at the end of the assigned antibiotic duration."}
• {"endpoint_text":"- 4.\tProportion of participants with complete regression of liver abscess(es) images at week 3, week 6, and week 12 after drainage.","definition_or_measurement_approach":"Imaging assessment (ultrasound or CT) at weeks 3, 6 and 12 to determine complete radiological regression."}
• {"endpoint_text":"- 5.\tTime to hospital discharge","definition_or_measurement_approach":"Measured as time from index event or randomisation to hospital discharge."}
• {"endpoint_text":"- 6.\tIntercurring events between week 12 and month 6 in each group (e.g. relapse of index infection, new liver abscess(es), death from any cause)","definition_or_measurement_approach":"Collection and description of intercurrent events occurring between week 12 and month 6 (relapse, new abscess, death, etc.)."}
• {"endpoint_text":"- 7.\tClinical, anatomical, and microbiological characteristics of the PLA. Clinical, biological and treatment characteristics of the patients.","definition_or_measurement_approach":"Descriptive characterization using clinical, imaging and microbiological data and patient clinical/biological/treatment data."}
• {"endpoint_text":"- 8.\tCharacteristics and modalities of the antibiotic therapy administered to the participant (molecules, modalities, duration).","definition_or_measurement_approach":"Descriptive collection of antibiotic agents used, modalities and durations per participant."}
• {"endpoint_text":"- 9. Proportion of patients with an extended ATB longer than the duration assigned by the randomisation.","definition_or_measurement_approach":"Proportion of patients whose antibiotic therapy was extended beyond the randomized duration."}
• {"endpoint_text":"- 10.\tProportion of patients with an appropriate ATB related to the bacterial documentation (intravenous and oral).","definition_or_measurement_approach":"Proportion meeting criteria for appropriate antibiotic therapy based on bacterial documentation (IV and oral)."}
• {"endpoint_text":"- 11.\tIncidence of adverse events and serious adverse events.","definition_or_measurement_approach":"Incidence rates of adverse events and serious adverse events collected during the study period."}

France

Earliest CTIS Part Ii Submission Date

30-07-2025

Latest Decision Or Authorization Date

06-10-2025

Processing Time Days

68

Number Of Sites

17

Number Of Participants

456

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Health Ministry","duties_or_roles":"Monetary support","organisation_type":""}