Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 20
- 主要终点
- percentage of patients receiving early discontinuation of EAT, defined as a discontinuation strictly before day 7 after EAT initiation
研究概览
简要总结
Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse.
The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality.
To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.
详细描述
Patients requiring EAT will be randomly assigned to:
- intervention group: a strategy in which EAT duration is determined by (1,3)-B-Dglucan and mannan serum assays, performed on day 0 (day of EAT initiation) and day 3. Early stop recommendation, provided before day 7, will be determined using an algorithm based on the results of biomarkers.
- control group: a routine care strategy, based on international guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.
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
- •Patient older than 18 years
- •Who require EAT for the first time in the ICU (this treatment is prescribed based on the presence of risk factors and clinical suspicion of ICI)
- •With an expected ICU length of stay of at least 6 days after EAT initiation
- •Informed written consent
排除标准
- •Neutropenia (neutrophil count <500 cells /µL)
- •Active malignant hemopathy
- •Bone marrow transplantation in the last 6 months
- •Polyvalent immunoglobulins in the past months
- •Documented ICI in the past 3 months
- •Pregnancy or breastfeeding
研究组 & 干预措施
Biomarker group
patient follow the Biomarker strategy
干预措施: Biomarker strategy (Other)
Routine group
patient follow the routine strategy
干预措施: Routine strategy (Other)
结局指标
主要结局
percentage of patients receiving early discontinuation of EAT, defined as a discontinuation strictly before day 7 after EAT initiation
时间窗: day 7 after EAT initiation
This trial is designed to demonstrate whether, in critically ill patients suspected for ICI, the biomarker strategy, as compared with a standard strategy, is at the same time: 1. superior in terms of antifungal use and 2. Non-inferior in terms of death
次要结局
- death from any cause(day 28 after EAT initiation)
- percentage of patients colonized with a resistant strain of Candida(at day 28 or ICU discharge, if it occurs before day 28)
- percentage of patients who presented a proven ICI after EAT discontinuation(at day 28 or ICU discharge, if it occurs before day 28)
- percentage of patients who received at least two periods of antifungal treatment (prescribed for separate episodes of suspected or proven ICI)(at day 28 or ICU discharge, if it occurs before day 28)
- intensity of Candida colonization during ICU stay(at day 28 or ICU discharge, if it occurs before day 28)
- antifungal-free days(at day 28 or ICU discharge, if it occurs before day 28)
- ventilator-free days(at day 28 or ICU discharge, if it occurs before day 28)
- ICU-free days(at day 28 or ICU discharge, if it occurs before day 28)
- ICU mortality(at day 28 or ICU discharge, if it occurs before day 28)
- day 90 mortality(at day 90)
- Characterization of the fungal intestinal microbiota studied by standard mycology(at baseline, at Day 7, day 14 day 21 and day 28)
- Characterization of the fungal intestinal microbiota studied by metagenomics(at baseline, at Day 7, day 14 day 21 and day 28)
- Characterization of the bacterial intestinal microbiota studied by culture bacteriology(at baseline, at Day 7, day 14 day 21 and day 28)