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

Chronic Obstructive Pulmonary Disease Clinical Trial

— ADMiRE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03641235
• Other study ID #: CHUBX 2018/17
• Status: Not yet recruiting
• Start date: September 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2018
• Source: University Hospital, Bordeaux
• Contact: Didier GRUSON, MD/PhD
• Phone: +335 56 79 55 17
• Email: didier.gruson[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Biological:
• Sputum collection
Analysis of Sputum collection

Locations

Country	Name	City	State
France	University Hospital, Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a diversity through the coefficient developed by Shannon and the ß diversity	Day 0
Primary	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 a diversity through the coefficient developed by Shannon and the ß diversity.	Day 0
Primary	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 a diversity and the ß diversity.	Day 0
Primary	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 a diversity through the coefficient developed by Shannon and the ß diversity	Day 60
Primary	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 a diversity through the coefficient developed by Shannon.	Day 60
Primary	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 a diversity and the ß diversity.	Day 60