2024-516266-11-00招募中3 期
Prospective multicenter randomized double-blind study comparing caspofungin to placebo for the treatment of ICU yeast intra-abdominal infection
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 448
- 试验地点
- 17
- 主要终点
- 28-day failure rate after the beginning of treatment
研究概览
简要总结
Decrease of failure rate at 28-day after the beginning of treatment in ITT analysis
研究设计
- 分配方式
- Randomized
- 主要目的
- Prospective multicenter randomized double-blind study
- 盲法
- Double (Investigator, Subject)
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
- 是
入选标准
- •Age ≥ 18 years old
- •Covered by national health insurance
- •Admitted to ICU after surgery for intra-abdominal infection : - With suspected intra-abdominal candidiasis defined by a Peritonitis score ≥ 3 - Or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected intraoperatively
- •With written and signed informed consent
排除标准
- •Allergy to caspofungin
- •Life expectancy ≤ 48h
- •Expected withdrawal of treatment
- •Radiological drainage without surgery
- •Severe hepatic impairment (Child-Pugh C score)
- •Pregnant or lactating women
结局指标
主要结局
28-day failure rate after the beginning of treatment
28-day failure rate after the beginning of treatment
次要结局
- 28 and 90-day mortality
- Success rate at the end of treatment
- Slope of ß-D-glucan concentrations
- 28-day mortality for subgroup analysis
研究者
DUPONT Hervé
Scientific
Centre Hospitalier Universitaire Amiens Picardie
研究点 (17)
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