MicrA: Pulmonary Microbiota and ARDS Mortality

• Sponsor: University of Bordeaux (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04133558
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Anticipated Duration (Months): 12.1
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Other: tracheal aspirate during routine care

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Association of Lung Microbiota With Intensive Care Unit Mortality in ARDS Patients: MicrA Study
• Actual Study Start Date: Oct 31, 2019
• Anticipated Primary Completion Date: Nov 1, 2020
• Anticipated Study Completion Date: Nov 1, 2020

Outcome Measures

Primary Outcome Measures

1. lung bacteriobiota and ICU mortality [at admission]

   Comparison of lung bacteriobiota alpha diversity between ARDS ICU survivors and non-survivors

Secondary Outcome Measures

1. lung mycobiota and ICU mortality [at admission]

   Comparison of lung mycobiota alpha diversity between ARDS ICU survivors and non-survivors

2. lung mycobiota and 1-month mortality [microbiota : at admission, mortality: 1 month after inclusion]

   Comparison of lung mycobiota alpha diversity between ARDS 1-month survivors and non-survivors

3. lung bacteriobiota and ICU mortality [at admission]

   Analysis of lung bacteriobiota beta diversity between ARDS ICU survivors and non-survivors

4. lung bacteriobiota and 1-month mortality [microbiota : at admission, mortality: 1 month after inclusion]

   Analysis of lung bacteriobiota beta diversity between ARDS 1-month survivors and non-survivors

5. lung mycobiota and ICU mortality [at admission]

   Analysis of lung mycobiota beta diversity between ARDS ICU survivors and non-survivors

6. lung mycobiota and 1-month mortality [microbiota : at admission, mortality: 1 month after inclusion]

   Analysis of lung mycobiota beta diversity between ARDS 1-month survivors and non-survivors

7. bacteria and ICU mortality [at admission]

   Association of bacteria with ARDS ICU mortality by LefSe method

8. bacteria and 1-month mortality [microbiota : at admission, mortality: 1 month after inclusion]

   Association of bacteria with ARDS 1-month mortality by LefSe method

9. fungi and ICU mortality [at admission]

   Association of fungi with ARDS ICU mortality by LefSe method

10. fungi and 1-month mortality [microbiota : at admission, mortality: 1 month after inclusion]

    Association of fungi with ARDS 1-month mortality by LefSe method

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical intensive care unit, Pellegrin hospital	Bordeaux	Nouvelle-Aquitaine	France	33000

Sponsors and Collaborators

• University of Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr Pauline Esteves, Doctor, University of Bordeaux
• ClinicalTrials.gov Identifier: NCT04133558
• Other Study ID Numbers: MicrA
• First Posted: Oct 21, 2019
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr Pauline Esteves, Doctor, University of Bordeaux: acute respiratory distress syndrome; microbiota; intensive care unit
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Nov 1, 2019