Performance of the Dosage of Plasma 1, 3-β-D-glucan (BDG) for the Diagnosis of Candidemia in Intensive Care Patients: A Prospective, Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Determine the sensitivity and specificity of the BDG for the diagnosis of candidemia in intensive care unit patients.
研究概览
简要总结
Systematic and repeated dosing (3 times weekly) of 1,3-β-D-glucan (BDG), associated with blood cultures and fungal mapping (twice a week) for the patients hospitalized in intensive care. The diagnosis of candidemia is defined as the 1st positive blood culture for Candida spp.
The dosage of BDG will be considered positive if the value is at least or equal to 80 pg/ml.
详细描述
The candidemia is the 3rd cause of sepsis in intensive care unit and a serious problem because the high mortality remains (> 50%) despite the new treatments by echinocandins.
A single positive blood culture is sufficient for diagnosis, but the sensitivity of blood cultures is only 50 to 70 percent. Clinical signs are unspecific and do not guide the diagnosis. If treatment started early, 12 hours after the 1st positive blood culture collection the mortality is 10%. Recently, the incidence of candidemia in intensive care unit has increased in France as in other countries as. From these different elements (frequency, mortality, early diagnosis, little specific clinical signs), it is easy to understand the approach that has prevailed for many years, which is to define the profile of the patients at risk of candidemia in intensive care unit. Currently, there are several predictive factors of occurrence of a candidemia in intensive care unit. They are represented by the index of colonization, very high risk factors (FTHR) and Candida score (CS).
Predictive factors of occurrence of candidemia have led to the concept of preemptive or empirical treatment, the aim is to being avoid the occurrence of candidemia.
However, the ability of these factors to predict the occurrence of a candidemia is not satisfactory, explaining in part the mortality rate.
In the light of current knowledge, including the predictive factors of occurrence of candidemia in intensive care patients, a better selection of patients likely to develop candidemia remains to this day, a crucial issue. Several teams have been interested in the evaluation of various bio-markers, including the (1,3) - β - D-glucan (BDG), to optimize decision-making in intensive care patients at risk of candidemia in front of:
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
- •Patients ≥ 18 years
- •Patients Under mechanical ventilation (MV), antibiotic (AB) And with a central venous catheter (CVK)
- •inclusion at day 4 of hospitalization or from establishing of antifungal treatment between admission to the Intensive Care Unit (ICU) and day 4
- •Affiliation to the social security system.
- •Signed informed consent
排除标准
- •Antifungal therapy at the admission in intensive care unit
- •Patient whose inclusion life expectancy is less than 72 h
- •Patient being treated for Pneumocystis carinii pneumonia (PCP)
- •Pregnant or breastfeeding woman
- •Neutropenia: < 500 nuclear neutrophil / mm3
- •Patients under ECMO
结局指标
主要结局
Determine the sensitivity and specificity of the BDG for the diagnosis of candidemia in intensive care unit patients.
时间窗: 30 day after inclusion
Systematic and repeated dosing , for the diagnosis of candidemia (1st positive blood culture for Candida spp). Dosage of BDG will be considered positive if a dosage is at least equal to 80 pg/ml or greater.
次要结局
未报告次要终点