EUCTR2018-000407-16-FR进行中（未招募）1 期
Prospective multicenter randomized double-blind study comparing caspofungin to placebo for the treatment of ICU yeast intra-abdominal infection - CASPER
CHU Amiens-Picardie0 个研究点目标入组 448 人开始时间: 2018年11月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 448
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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(1)
- •-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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 298
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 149
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
研究者
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