2025-520940-14-00招募中4 期
TIME-TO-LIA : Optimal Duration of Antibiotic Therapy in Drained Pyogenic Liver Abscess: 3 weeks versus 6 weeks, a non-inferiority trial
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 456
- 试验地点
- 11
- 主要终点
- Proportion of patients with a treatment failure between the end of treatment and week 12 after the drainage of the abscess(es).
研究概览
简要总结
Demonstrate that an antibiotic therapy (ATB) of 3 weeks after drainage of pyogenic liver abscess is non-inferior in terms of treatment failure at week 12 after drainage, compared to a 6 weeks ATB.
研究设计
- 分配方式
- Randomized
- 主要目的
- Time To Lia
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Intra-hepatic abscess assessed by radiological evaluation (CT)
- •Bacterial confirmation by culture of pus extracted from liver abscess
- •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.
排除标准
- •Non pyogenic bacterial aetiology of PLA: fungal, parasitic, mycobacterial, or absence of documentation
- •Patient under guardianship or trusteeship
- •Subject already involved in another interventional clinical research evaluating a medicinal product
- •Subject already involved in another interventional clinical research evaluating an interventional procedure for PLA treatment
- •Extra-hepatic abscess or infection in another site for which the duration of ATB would be longer than 3 weeks.
- •PLA occurring after liver transplantation or in a liver recipient patient.
- •Ischemic cholangitis as aetiology of PLA
- •Associated other(s) liver abcess(es) > 3 cm with no drainage possible
- •Contraindications to investigational medicinal products
- •Pregnant / breastfeeding women
- •Non-affiliation to a social security regimen or CMU
- •Patient refusal to participate or no possibility to give consent
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Proportion of patients with a treatment failure between the end of treatment and week 12 after the drainage of the abscess(es).
Proportion of patients with a treatment failure between the end of treatment and week 12 after the drainage of the abscess(es).
次要结局
- 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.
研究者
Geoffrey ROSSI
Scientific
Assistance Publique Hopitaux De Paris
研究点 (11)
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