- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03641235
Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care Unit (ADMiRE)
Analysis of the Dynamics of the Lung Microbiota During Acute Exacerbation of COPD Requiring Admission to Intensive Care
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Bordeaux, Francia, 33000
- University Hospital, Bordeaux
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
exacerbating COPD patients needing ICU admission
sputum collection
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Analysis of Sputum collection
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of differents types of cyto-bacteriological of sputum in Bacteriology
Lasso di tempo: 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
|
Day 0
|
Number of differents types of Cyto-bacteriological of sputum in Mycology
Lasso di tempo: 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.
|
Day 0
|
Number of differents types of Cyto-bacteriological of sputum in Virology
Lasso di tempo: 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.
|
Day 0
|
Number of differents types of Cyto-bacteriological of sputum in Bacteriology
Lasso di tempo: 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
|
Day 60
|
Number of differents types of Cyto-bacteriological of sputum in Mycology
Lasso di tempo: 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.
|
Day 60
|
Number of differents types of Cyto-bacteriological of sputum in Virology
Lasso di tempo: 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.
|
Day 60
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Didier GRUSON, MD/PhD, Hospital University, Bordeaux
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CHUBX 2018/17
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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