NCT00462657Unknown不适用
Early Diagnosis of Invasive Aspergillosis in a High Risk Group of Patients Using Serum and Bronchoalveolar Lavage Fluid Real Time PCR and Galactomannan ELISA
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Sensitivity and specificity of galactomannan (GM) ELISA and real time PCR in detecting invasive aspergillosis (IA)
研究概览
简要总结
RATIONALE: Studying ways to diagnose fungal infections early may help doctors plan the best treatment.
PURPOSE: This clinical trial is studying laboratory tests to see how well they find aspergillosis early in patients at high risk of fungal infection caused by treatment for hematologic cancer or other disease.
详细描述
OBJECTIVES:
Primary
- Determine the test characteristics of galactomannan (GM) ELISA using serum and bronchoalveolar lavage fluid (BALF) collected from patients at high risk of invasive fungal infection.
- Determine the test characteristics of aspergillus PCR using blood and BALF samples collected from these patients.
- Evaluate the role of noninvasive exhaled breath condensate (EBC) in detecting invasive aspergillosis (IA).
- Determine whether repeated measures over time or a combination of markers improves the test characteristics.
- Establish cutoff points for the diagnosis of IA.
Secondary
- Determine the inflammatory marker and cytokine profile of EBC in fungal infection and after bone marrow transplantation as a marker of acute lung injury.
- Assess the role of bronchoscopy with bronchoalveolar lavage in identifying the causal pathogen early in the disease course of febrile neutropenic patients.
- Assess the role of GM ELISA in prognosis and response to treatment for IA.
- Assess the role of aspergillus PCR in prognosis and response to treatment for IA.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensitivity and specificity of galactomannan (GM) ELISA and real time PCR in detecting invasive aspergillosis (IA)
Diagnostic value of IA screening by GM ELISA and real time PCR, in terms of positive and negative predicative values
次要结局
未报告次要终点
研究者
研究点 (4)
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