Clinical trial NCT03641235: Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care Unit
Official title: Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: pulmonary microbiota
Chronic obstructive pulmonary disease
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of differents types of cyto-bacteriological of sputum in Bacteriology
timeFrame: Day 0
measure: Number of differents types of Cyto-bacteriological of sputum in Mycology
timeFrame: Day 0
measure: Number of differents types of Cyto-bacteriological of sputum in Virology
timeFrame: Day 0
measure: Number of differents types of Cyto-bacteriological of sputum in Bacteriology
timeFrame: Day 60
measure: Number of differents types of Cyto-bacteriological of sputum in Mycology
timeFrame: Day 60
measure: Number of differents types of Cyto-bacteriological of sputum in Virology
timeFrame: Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital, Bordeaux
Study officials:
affiliation: Hospital University, Bordeaux
name: Didier GRUSON, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: