A Molecular Toolkit for the Microbial Investigation of Severe Community Acquired Pneumonia (S-CAP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples
研究概览
简要总结
Severe community acquired pneumonia is common and associated with high mortality. Conventional microbiological diagnostics identify pathogens in approximately half of cases, which is inadequate for both clinical and epidemiological purposes. This study applies next-generation sequencing based metagenomic techniques to patients with extremely severe community acquired pneumonia, to investigate the microbiome of severe community acquired pneumonia and evaluate metagenomic approaches as diagnostic tools.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Adults aged 18 or over
- •Admitted to a participating severe respiratory failure centre or ICU
- •Admitted due to community acquired pneumonia (CAP) according to clinical and radiological criteria
- •Tracheal intubation, receiving mechanical ventilation +/- ECMO
- •Requires bronchoscopy as part of routine diagnostic care plan
- •Bronchoscopy takes place within 72 hours of first admission to hospital
排除标准
- •Any current or previous condition/circumstance that, in the opinion of the investigator or study nurse, may put the individual at risk if participating
- •Patients receiving end of life care
- •Hospitalisation within the previous 28 days (not including pre-ECMO hospitalisation for ECMO patients)
- •Consent or assent not given
结局指标
主要结局
Detection of pathogens by metagenomic sequencing applied to bronchoalveolar lavage samples
时间窗: 28 days (From time of enrollment up until end of inclusion)
The proportion of pathogen genome that can be detected in bronchial lavage samples detected by the proportion of the sequenced nucleic acid which is pathogen derived and the proportion of the pathogen genome which be reconstructed.
次要结局
- Metagenomic detection of pathogen genomes compared to the results of conventional diagnostic techniques(28 days (From time of enrollment up until end of inclusion))