NCT04133558

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

October 31, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

October 16, 2019

Last Update Submit

October 31, 2019

Conditions

Acute Respiratory Distress Syndrome

Keywords

acute respiratory distress syndromemicrobiotaintensive care unit

Outcome Measures

Primary Outcomes (1)

  • lung bacteriobiota and ICU mortality

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

    at admission

Secondary Outcomes (10)

  • lung mycobiota and ICU mortality

    at admission

  • lung mycobiota and 1-month mortality

    microbiota : at admission, mortality: 1 month after inclusion

  • lung bacteriobiota and ICU mortality

    at admission

  • lung bacteriobiota and 1-month mortality

    microbiota : at admission, mortality: 1 month after inclusion

  • lung mycobiota and ICU mortality

    at admission

  • +5 more secondary outcomes

Interventions

tracheal aspirate during routine careOTHER

tracheal aspirate during routine care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Guardianship or curatorship
  • Prisoners
  • No health insurance
  • No legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical intensive care unit, Pellegrin hospital

Bordeaux, Nouvelle-Aquitaine, 33000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

tracheal aspirate

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 21, 2019

Study Start

October 31, 2019

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)