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Clinical Trials/NCT03641235
NCT03641235
Unknown
Not Applicable

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

University Hospital, Bordeaux1 site in 1 country24 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
University Hospital, Bordeaux
Enrollment
24
Locations
1
Primary Endpoint
Number of differents types of Cyto-bacteriological of sputum in Bacteriology
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
September 1, 2020
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of differents types of Cyto-bacteriological of sputum in Bacteriology

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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