NCT01430663已完成不适用
Diagnosing Pulmonary Aspergillosis in Patients With Hematological Malignancies: A Multicentre Prospective Evaluation of an Aspergillus PCR Assay and a Galactomannan ELISA in Bronchoalveolar Lavage Samples
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 9
- 主要终点
- Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis
研究概览
简要总结
Diagnosing invasive pulmonary aspergillosis (IPA) remains a challenge in patients (pts) with hematological malignancies. The clinical significance of testing bronchoalveolar lavage (BAL) samples both with polymerase chain reaction (PCR) and Aspergillus galactomannan (GM) ELISA is unclear, and the BAL cutoff for GM has not been clearly defined yet. Using a validated nested PCR assay and a GM ELISA, we prospectively examine BAL samples from hematological patients at high risk of PA.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hematological patients with lung infiltrates at high risk for invasive aspergillosis
排除标准
- •patients without informed consent
结局指标
主要结局
Clinical significance of biomarker based diagnostic investigation in suspected invasive aspergillosis
时间窗: up to 18 months
次要结局
- Evaluation of diagnostic and therapeutic intervention concerning antifungal treatment with regard to outcome (overall survival, in months) of a fungal infection(up to 18 months)
研究者
Dieter Buchheidt
Prof. Dr. med.
Heidelberg University
研究点 (9)
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