Pulmonary Microbiota and ARDS Mortality (MicrA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• France
  • Nouvelle-Aquitaine
    • Bordeaux, Nouvelle-Aquitaine, France, 33000
      • Recruiting
      • Medical intensive care unit, Pellegrin hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ARDS patients needing oro-tracheal intubation for mechanical ventilation in ICU

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lung bacteriobiota and ICU mortality	Comparison of lung bacteriobiota alpha diversity between ARDS ICU survivors and non-survivors	at admission

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Bordeaux

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2019
• Primary Completion (ANTICIPATED): November 1, 2020
• Study Completion (ANTICIPATED): November 1, 2020

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (ACTUAL): October 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: intensive care unit; microbiota; acute respiratory distress syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: Micra

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No