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

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ClinicalTrials.gov Identifier: NCT03641235
Recruitment Status : Unknown
Verified July 2018 by University Hospital, Bordeaux.
Recruitment status was:  Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Biological: Sputum collection

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
exacerbating COPD patients needing ICU admission
sputum collection
 Biological: Sputum collection
Analysis of Sputum collection


Outcome Measures
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Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Sputum

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641235


Contacts
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Contact: Didier GRUSON, MD/PhD +335 56 79 55 17 didier.gruson@chu-bordeaux.fr
Contact: Renaud PREVEL, MD MSc +335 56 79 55 17 renaud.prevel@u-bordeaux.fr

Locations
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France
University Hospital, Bordeaux
Bordeaux, France, 33000
Contact: Didier GRUSON, MD,PhD    +335 56 79 55 17    didier.gruson@chu-bordeaux.fr   
Contact: Renaud PREVEL    +335 56 79 55 17    renaud.prevel@u-bordeaux.fr   
Principal Investigator: Didier GRUSON, MD,PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Didier GRUSON, MD/PhD Hospital University, Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03641235    
Other Study ID Numbers: CHUBX 2018/17
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
pulmonary microbiota
Chronic obstructive pulmonary disease
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases