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Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care Unit (ADMiRE)

2018年8月17日 更新者：University Hospital, Bordeaux

Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care

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

研究概览

地位

未知

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (预期的)

24

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 法国
      • Bordeaux、法国、33000
        • University Hospital, Bordeaux

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

Inclusion Criteria:

  • 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

Exclusion Criteria

- Lung function testing not consistent with COPD at steady-state visit

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
exacerbating COPD patients needing ICU admission
sputum collection
生物：Sputum collection
Analysis of Sputum collection

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of differents types of cyto-bacteriological of sputum in Bacteriology
大体时间：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
Day 0
Number of differents types of Cyto-bacteriological of sputum in Mycology
大体时间：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.
Day 0
Number of differents types of Cyto-bacteriological of sputum in Virology
大体时间：Day 0
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.
Day 0
Number of differents types of Cyto-bacteriological of sputum in Bacteriology
大体时间：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
Day 60
Number of differents types of Cyto-bacteriological of sputum in Mycology
大体时间：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.
Day 60
Number of differents types of Cyto-bacteriological of sputum in Virology
大体时间：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.
Day 60

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Bordeaux

调查人员

  • 首席研究员：Didier GRUSON, MD/PhD、Hospital University, Bordeaux

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2018年9月1日

初级完成 (预期的)

2020年9月1日

研究完成 (预期的)

2020年9月1日

研究注册日期

首次提交

2018年7月13日

首先提交符合 QC 标准的

2018年8月17日

首次发布 (实际的)

2018年8月21日

研究记录更新

最后更新发布 (实际的)

2018年8月21日

上次提交的符合 QC 标准的更新

2018年8月17日

最后验证

2018年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CHUBX 2018/17

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Sputum collection的临床试验

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医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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