Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- failure rate after the beginning of treatment
研究概览
简要总结
The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. Prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. The aim of this study is to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.
详细描述
The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. These infections are clearly associated with increased morbidity and mortality in both community-acquired and healthcare-associated infections. So far,prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. No prospective randomized trial has been conducted on intra-abdominal candidiasis and most retrospective analyses have reported very conflicting results concerning the impact of treatment on outcome. The aim of this study is therefore to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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
- •Immunodepression (treatment including long-term corticosteroids, anti-TNF or disease including transplant patients)
- •Infected acute pancreatitis
- •Ascites fluid infection
研究组 & 干预措施
placebo
placebo
干预措施: placebo (Other)
antifungal therapy
caspofungin
干预措施: caspofungin antifungal therapy (Drug)
结局指标
主要结局
failure rate after the beginning of treatment
时间窗: 28 days
28-day failure rate after the beginning of treatment
次要结局
- mortality(28 days)
- success rate at the end of treatment(8 days)
- slope of ß-D-glucan concentrations(8 days)