Staging Candidiasis in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 422
- 试验地点
- 2
- 主要终点
- Number of positive Candidiasis tests
研究概览
简要总结
Our primary objective is to evaluate the relevance of the early determination of Candida infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Polynuclear neutrophils > 500/mm^3
- •Hospitalized for > 48 hours in participating ICUs
排除标准
- •Patients discharged from ICU in < 48h
- •Patient diagnosed with invasive candidosis before entry to ICU
- •Patient is taking an anti-fungal treatment
- •polynuclear neutrophils < 500/mm^3
- •patient transferred to another ICU
- •patient included in the Abmidex protocole
研究组 & 干预措施
The study population
The target population includes patients in ICUs at the Nîmes and Montpellier University hospitals. This is a population of non-neutropenic patients (polynuclear neutrophils > 500/mm3) at risk of developing invasive candidiasis.
干预措施: Tests for candidiasis (Biological)
结局指标
主要结局
Number of positive Candidiasis tests
时间窗: 7 days
Number of tests (score of 0 to 4) positive for Candida. Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of ciruclating Candida DNA via SYBR Breen qPCR Master mix; (4) colonization index based on mycological examination of five out of the following: urine, oral swab, bronchial aspirate, anal swab, swab of a central venous line, gastric liquid.
次要结局
- Number of positive Candidiasis tests(2 days)
- Patient leaves ICU unit, yes/no(1 month)
- Patient passes away in ICU unit, yes/no(1 month)
- Patient has been prescribed an antifungal treatment in the past month, yes/no(1 month)