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Completed

NCT Number: NCT03641235

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sputum collection

Biological

Analysis of Sputum collection

Primary outcomes

  1. 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

  2. Number of differents types of Cyto-bacteriological of sputum in Mycology

    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.

  3. Number of differents types of Cyto-bacteriological of sputum in Virology

    Time frame: 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.

  4. 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

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: ADMiRE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2018
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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