Pulmonary Microbiota and ARDS Mortality

Acute Respiratory Distress Syndrome Clinical Trial

— MicrA  

Official title:

Association of Lung Microbiota With Intensive Care Unit Mortality in ARDS Patients: MicrA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04133558
• Other study ID #: MicrA
• Status: Recruiting
• Start date: October 31, 2019
• Est. completion date: November 1, 2020

Study information

• Verified date: October 2019
• Source: University of Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute respiratory distress syndrome (ARDS) is due to diffuse and severe lung inflammation. Despite intensive research, few therapeutics have emerged and treatment is still mostly symptomatic. As lung microbiota seems to be associated with lung inflammation in numerous chronic respiratory diseases, this study aims to analyse the correlation between lung microbiota and mortality.

Description:

ARDS is caused by diffuse intense lun inflammation. Its mortality rate is still about 40%. Despite decades of research, few therapeutics have emerged. Treatment is based on the treatment of ARDS cause, if possible and on protective ventilation, curare use and prone position. For more severe cases, nitric monoxide inhalation and extra-corporeal membrane oxygenation can be considered. Nevertheless, no treatment specifically addresses lung inflammation. Lung microbiota has been shown to be associated with lung inflammation in asthma, chronic obstructive disease and cystic fibrosis. Lung microbiota also plays a role in lung immunity. Regarding specifically ARDS, one study correlated lung microbiota with the occurrence of non-infectious ARDS in trauma patients. Thi study therefore aims to analyse the correlation between lung microbiota at admission to ICU for ARDS with mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient above 18 year-old admitted to intensive care unit

• ARDS according to Berlin criteria

• Needing oro-tracheal intubation for mechanical ventilation

• Within the first 48 hours of ARDS evolution

Exclusion Criteria:

• Guardianship or curatorship

• Prisoners

• No health insurance

• No legal representative

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• tracheal aspirate during routine care
tracheal aspirate during routine care

Locations

Country	Name	City	State
France	Medical intensive care unit, Pellegrin hospital	Bordeaux	Nouvelle-Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung bacteriobiota and ICU mortality	Comparison of lung bacteriobiota alpha diversity between ARDS ICU survivors and non-survivors	at admission
Secondary	lung mycobiota and ICU mortality	Comparison of lung mycobiota alpha diversity between ARDS ICU survivors and non-survivors	at admission
Secondary	lung mycobiota and 1-month mortality	Comparison of lung mycobiota alpha diversity between ARDS 1-month survivors and non-survivors	microbiota : at admission, mortality: 1 month after inclusion
Secondary	lung bacteriobiota and ICU mortality	Analysis of lung bacteriobiota beta diversity between ARDS ICU survivors and non-survivors	at admission
Secondary	lung bacteriobiota and 1-month mortality	Analysis of lung bacteriobiota beta diversity between ARDS 1-month survivors and non-survivors	microbiota : at admission, mortality: 1 month after inclusion
Secondary	lung mycobiota and ICU mortality	Analysis of lung mycobiota beta diversity between ARDS ICU survivors and non-survivors	at admission
Secondary	lung mycobiota and 1-month mortality	Analysis of lung mycobiota beta diversity between ARDS 1-month survivors and non-survivors	microbiota : at admission, mortality: 1 month after inclusion
Secondary	bacteria and ICU mortality	Association of bacteria with ARDS ICU mortality by LefSe method	at admission
Secondary	bacteria and 1-month mortality	Association of bacteria with ARDS 1-month mortality by LefSe method	microbiota : at admission, mortality: 1 month after inclusion
Secondary	fungi and ICU mortality	Association of fungi with ARDS ICU mortality by LefSe method	at admission
Secondary	fungi and 1-month mortality	Association of fungi with ARDS 1-month mortality by LefSe method	microbiota : at admission, mortality: 1 month after inclusion