NCT03117439已完成不适用
(1-3)-Beta-D-Glucan Driven vs. Empirical Antifungal Therapy in High Risk Critically Ill Patients A Randomized Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach
研究概览
简要总结
This study is aimed to compare the duration of standard anti fungal therapy in high risk ICU patients with a strategy driven by BetaDGlucan test result
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •ICU admission (minimum of 48 hours in ICU with an expected length of stay of at least 48 hours)
- •Ongoing Mechanical Ventilation
- •Presence of CVC
- •Sepsis/Septic Shock development while receiving broad spectrum antibiotics
- •Positivity of Candida Score or Candida Colonization Index in absence of septic shock
排除标准
- •Complicated Candida Infection
- •Already ongoing anti fungal therapy
- •Beta Glucan test not available
- •Absence of informed consent
- •Immunesuppressive status (long-term immunesuppresive or steroids therapy; AIDS; WBC <1000/mmc or neutrophils <500/mmc)
- •Pregnancy
- •Already enrolled in other interventional studies
研究组 & 干预措施
Control Group
No Intervention
Patients undergoing empirical anti fungal therapy. Interruption of anti fungal treatment will be decided on the basis of standard clinically and microbiologically criteria.
1-3 Beta-D-Glucan Group
Experimental
Patients undergoing anti fungal de-escalation according to 1-3 Beta-D-Glucan results
干预措施: duration of antifungal therapy (Other)
结局指标
主要结局
Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach
时间窗: First 30 days from enrollment
次要结局
- 30-day mortality(30 days)
- Duration of ICU length of stay(90 days)
- Cost evaluation (empirical anti fungal therapy vs. Beta Glucan test)(30 days)
- Number of invasive Candida Infections and Beta-Glucan accuracy(90 days)
- ICU mortality(90 days)
- Clinical Cure of Invasive Canididiasis(90 days)
- Microbiological eradication of Invasive Candidiasis(90 days)
- Hospital mortality(90 days)
- Duration of mechanical ventilation(90 days)
研究者
研究点 (1)
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