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- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Bordeaux, França, 33000
- University Hospital, Bordeaux
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
exacerbating COPD patients needing ICU admission
sputum collection
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Analysis of Sputum collection
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of differents types of cyto-bacteriological of sputum in Bacteriology
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Didier GRUSON, MD/PhD, Hospital University, Bordeaux
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CHUBX 2018/17
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