Diagnostic Value of PCR Genetic Amplification and Mannan Antigenemia Coupled With Antimannan Antibodies in Intensive Care Patients With Suspected Invasive Candidiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from the start of treatment in genomic DNA of Candida sp. by quantitative PCR
研究概览
简要总结
The study consists in taking 4 tubes of blood at different times over a period of 10 days, via a catheter (central venous or arterial catheter) already in place in the usual therapeutic management. These samples will make it possible to measure blood levels of certain markers specific to invasive candidiasis. PCR will be used to quantify fungal load precisely, that is to say the quantity of yeast present in the blood and to monitor this quantity over time.
These samples will be transferred to a specialized unit and stored for a maximum of three years for use at the end of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient informed about the study
- •Patients aged at least 18 years admitted to a medical Intensive Care or general intensive care
- •Patients with suspected invasive candidiasis - that is to say:
- •Presenting persistent sepsis despite broad-spectrum antibiotherapy for at least 48 hours or targeted antibiotherapy for a documented bacterial infection (sepsis will be defined according to:
- •the usual SIRS criteria, at least 2 of the following 4: temperature > 38°C or < 36°C, tachycardia > 90/min, respiratory rate > 20/min or blood pressure carbon dioxide (PaCO2 ) < 32 mmHg, leukocytosis > 12000/mm3 or < 4000/mm3 or > 10% of immature forms.
- •Persistent hemodynamic instability (impossibility to significantly diminish catecholamine requirement, need for rapid vascular resuscitation > 1000 ml over the previous 24 hours)
- •Candida score ≥ 3 with multifocal colonization
- •Decision to initiate echinocandin therapy made by the clinician in charge of the patient
排除标准
- •Treatment with echinocandin > 1 day in the week preceding inclusion
- •Patients not covered by national health insurance
- •Pregnant or breast-feeding women
结局指标
主要结局
Change from the start of treatment in genomic DNA of Candida sp. by quantitative PCR
时间窗: At day 1, day 3, day 5, Day 7 and Day 10 after the start of antifungal treatment with echinocandin.
次要结局
- Change from the start of treatment in mannan antigenemia and antimannan antibodies(At day 1, day 5 and day 10 after the start of treatment)