Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- percentage of early discontinuation of empiric antifungal therapy
研究概览
简要总结
The investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in ICU patients.
详细描述
The duration of empirical/preemptive anti fungal treatment will be based in the intervention group on biomarker results.
Biomarkers of fungal disease will performed before starting anti fungal treatment and at day 4.
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
- 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
- •Age > or = 18 years
- •Patients requiring empiric antifungal therapy the first time in the ICU
- •Predictable duration of hospitalization in the ICU ≥ 6 days
排除标准
- •Neutropenia (WBC <1000 or neutrophils <500/mm3)
- •Immunosuppressive therapy (chemotherapy within 3 months prior to the ICU admission, solid organ graft under immunosuppressive therapy)
- •invasive fungal infection documented in the three previous months
- •Antifungal treatment in the three previous months
- •Pregnant or lactating women
研究组 & 干预措施
Biomarker group
Intervention group, in which the duration of empirical antifungal therapy will be based on the results of biomarkers.
Biomarker group
干预措施: Biomarker group (Other)
Control group
Control group, in which the duration of empirical antifungal therapy will be based on international recommendations (14 days).
结局指标
主要结局
percentage of early discontinuation of empiric antifungal therapy
时间窗: 7 days
Early discontinuation is defined as discontinuation of anti fungal treatment before the 7th day after the start of treatment
次要结局
- mortality in ICU(28 days after ICU admission)
- the cost of the antifungal therapy on a per duration prescribe(28 days after ICU admission)
- the cost of hospital stays(28 days after ICU admission)
- duration of mechanical ventilation and ICU stay(28 days after ICU admission)
- fungal colonization / infection after antifungal therapy, with or without resistant strains(28 days after ICU admission)