Microbiological Diagnostic Performance of Metagenomic Next-generation Sequencing for Pulmonary Infection in Clinical Settings
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- microbiological diagnosis (pathogen of pulmonary infection)
研究概览
简要总结
Pulmonary infections remain the leading causes of morbidity and mortality among patients worldwide. Pathogen identification is crucial yet difficult for the majority of the cases. Metagenomic Next-generation Sequencing provides a potential technology for rapid and untargeted pathogen detection for pulmonary infection. The study is designed observationally to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional paradigm of serial tests wil be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary infection as the primary diagnosis
- •Bronchoalveolar lavage fluid can be obtained
排除标准
- •when the primary diagnosis is tumor or connective tissue diseases
- •microbiological diagnosis is confirmed before bronchoalveolar lavage
- •not enough bronchoalveolar lavage fluid for mNGS
结局指标
主要结局
microbiological diagnosis (pathogen of pulmonary infection)
时间窗: through study completion, up to 6 months
the final microbiological diagnosis (pathogen of pulmonary infection) after using of every detection method and combined with clinical manifestations.
次要结局
未报告次要终点
研究者
Jian-cang Zhou M.D.
Department of Infectious Diseases
Sir Run Run Shaw Hospital