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 IRCCS2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 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
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
- Duration of mechanical ventilation(90 days)
- 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)
研究者
研究点 (2)
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