Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Number of differents types of Cyto-bacteriological of sputum in Bacteriology
研究概览
简要总结
This study aims to investigate the correlation between pulmonary microbiota dynamics (including bacteria, fungi and viruses) and COPD exacerbation for COPD patients admitted to ICU
详细描述
Chronic obstructive pulmonary disease (COPD) is a frequent cause of ICU admission. COPD exacerbations are a leading cause of lung function worsening and of morbimortality. Hospitalizations due to COPD exacerbations are highly expensive for health insurance system. Bacterial pulmonary microbiota has been shown to be correlated to the severity of COPD and to exacerbations. Nevertheless fungi and viruses which are full actors of pulmonary microbiota have not yet been investigated.
Our primary outcome will be the assessment of alpha and beta diversity dynamics of the whole pulmonary microbiota (bacteria, fungi and viruses) between COPD exacerbation and steady state.
This study will prospectively include 24 patients at ICU admission for COPD exacerbation with sputum sampling. Steady-state as defined during a 2 months-later visit will be studied with another sputum collection.
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
- 否
入选标准
- •Patient above 18 admitted in ICU
- •Admitted for COPD exacerbation defined by sustained (> 2 days) worsening of respiratory symptoms considering Anthonisen's criteria with life-threatening condition.
- •Needing mechanical ventilation (noninvasive ventilation or oro-tracheal intubation)
- •COPD condition will be presumed according to patient's respiratory history or previous lung function testing
- •Able to consent or with the patient's family consent
- •Affiliated to a social insurance scheme
- •No inclusion Criteria:
- •COPD patient admitted for another cause than respiratory failure
- •person under tutorship or curatorship
- •living further than 100 kilometers away from the ICU
- •expected survival inferior to 1 week
排除标准
- •- Lung function testing not consistent with COPD at steady-state visit
结局指标
主要结局
Number of differents types of Cyto-bacteriological of sputum in Bacteriology
时间窗: Day 60
After extraction of the DNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity through the coefficient developed by Shannon and the β diversity
Number of differents types of cyto-bacteriological of sputum in Bacteriology
时间窗: Day 0
After extraction of the DNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity through the coefficient developed by Shannon and the β diversity
Number of differents types of Cyto-bacteriological of sputum in Mycology
时间窗: Day 60
After extraction of the DNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity through the coefficient developed by Shannon.
Number of differents types of Cyto-bacteriological of sputum in Virology
时间窗: Day 60
After extraction of the RNA and sequencing, the obtained sequences allow a taxonomic assignment of the microorganisms. The number of different taxonomic groups and the number of sequences within each taxonomic group to evaluate the α diversity and the β diversity.
次要结局
未报告次要终点