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

NCT03641235 | Unknown

• 1 other identifier: CHUBX 2018/17
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

pulmonary microbiota; Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (6)

• Number of differents types of cyto-bacteriological of sputum in Bacteriology

  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

  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

  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

  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

  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

  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

Study Arms (1)

exacerbating COPD patients needing ICU admission

sputum collection

Biological: Sputum collection

Interventions

Sputum collection BIOLOGICAL

Analysis of Sputum collection

exacerbating COPD patients needing ICU admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital, Bordeaux

Bordeaux, 33000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Didier GRUSON, MD/PhD

  Hospital University, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Didier GRUSON, MD/PhD

CONTACT

+335 56 79 55 17; didier.gruson@chu-bordeaux.fr

Renaud PREVEL, MD MSc

CONTACT

+335 56 79 55 17; renaud.prevel@u-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: August 21, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 21, 2018

Record last verified: 2018-07

Locations

FR (1)