NCT02851680已完成不适用
Prospective Study on the Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 476
- 试验地点
- 2
- 主要终点
- Comparison of the results of the 1-3 ß D glucan serum assay obtained with the Fungitell® test and the test currently used (in terms of specificity, sensitivity, negative predictive value and positive predictive value
研究概览
简要总结
In the context of screening for infectious fungal diseases in patients with malignant haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate the performance of an already commercialized but little used serum screening test (Fungitell® test) and to determine its place in the management strategy for invasive aspergillosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have been informed about the study
- •Patients over 18 years
- •patients with acute myeloblastic leukaemia (AML) or lymphoblastic leukaemia (ALL) who have undergone cytotoxic chemotherapy with curative intent
排除标准
- •Adults under guardianship
- •Patients without national health insurance cover
- •Pregnant or breast-feeding women
- •allografts and autografts of Haematopoietic Stem Cells (HSC)
结局指标
主要结局
Comparison of the results of the 1-3 ß D glucan serum assay obtained with the Fungitell® test and the test currently used (in terms of specificity, sensitivity, negative predictive value and positive predictive value
时间窗: 8 to 10 assays over 4 to 5 weeks of hospitalization
次要结局
未报告次要终点
研究者
研究点 (2)
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