Chronic Obstructive Pulmonary DiseaseADMiRENCT03641235
Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care Unit
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Bordeaux at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Sputum collection
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 2 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Lung function testing not consistent with COPD at steady-state visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care
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
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Sputum collection
- Keywords
- pulmonary microbiota, Chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum collectionBiological
Analysis of Sputum collection
| Study group | Role | What they receive |
|---|---|---|
| exacerbating COPD patients needing ICU admission | sputum collection Receives: Biological: Sputum collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 Sep 2018
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier GRUSON, MD/PhD, Principal investigator, Hospital University, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641235
- Sponsor's protocol ID
- CHUBX 2018/17
- Acronym
- ADMiRE
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Enaud R, Sioniac P, Imbert S, Janvier PL, Camino A, Bui HN, Pillet O, Orieux A, Boyer A, Berger P, Gruson D, Delhaes L, Prevel R. Lung Mycobiota alpha-Diversity Is Linked to Severity in Critically Ill Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Microbiol Spectr. 2023 Apr 13;11(2):e0506222. doi: 10.1128/spectrum.05062-22. Epub 2023 Mar 28.
PubMed 36976010
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care
- ClinicalTrials.gov ID
- NCT03641235
- Acronym / sponsor ID
- ADMiRE / CHUBX 2018/17
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- pulmonary microbiota, Chronic obstructive pulmonary disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exacerbating COPD patients needing ICU admission | – | Biological: Sputum collectionsputum collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- Lung function testing not consistent with COPD at steady-state visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sputum collectionAnalysis of Sputum collection | Biological | exacerbating COPD patients needing ICU admission |
Primary outcome
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 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 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.
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Results publication: PubMed 36976010Enaud R, Sioniac P, Imbert S, Janvier PL, Camino A, Bui HN, Pillet O, Orieux A, Boyer A, Berger P, Gruson D, Delhaes L, Prevel R. Lung Mycobiota alpha-Diversity Is Linked to Severity in Critically Ill Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Microbiol Spectr. 2023 Apr 13;11(2):e0506222. doi: 10.1128/spectrum.05062-22. Epub 2023 Mar 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier GRUSON, MD/PhD principal investigator
Hospital University, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of differents types of cyto-bacteriological of sputum in Bacteriology (time frame: Day 0). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03641235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.