Acute Respiratory Distress SyndromeMicrANCT04133558
Pulmonary Microbiota and ARDS Mortality
An observational study of Acute Respiratory Distress Syndrome, run by University of Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- tracheal aspirate during routine care
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2019to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ARDS patients needing oro-tracheal intubation for mechanical ventilation in ICU
Who may be able to join
- 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
Who cannot join
- Guardianship or curatorship
- Prisoners
- No health insurance
- No legal representative
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Medical intensive care unit, Pellegrin hospital
Bordeaux, New Aquitaine, 33000
Didier Gruson, Prof, +33556795679, didier.gruson@chu-bordeaux.fr
Renaud Prevel, MD, PhD, +33556795679, renaud.prevel@u-bordeaux.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- tracheal aspirate during routine care
- Keywords
- acute respiratory distress syndrome, microbiota, intensive care unit
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal aspirate during routine careOther
tracheal aspirate during routine care
What is being measured
The primary outcome is the main question the study is designed to answer.
lung bacteriobiota and ICU mortality
Comparison of lung bacteriobiota alpha diversity between ARDS ICU survivors and non-survivors
Measured: at admission
Secondary outcomes (10)
lung mycobiota and ICU mortality
Comparison of lung mycobiota alpha diversity between ARDS ICU survivors and non-survivors
Measured: at admission
lung mycobiota and 1-month mortality
Comparison of lung mycobiota alpha diversity between ARDS 1-month survivors and non-survivors
Measured: 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
Measured: at admission
lung bacteriobiota and 1-month mortality
Analysis of lung bacteriobiota beta diversity between ARDS 1-month survivors and non-survivors
Measured: 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
Measured: at admission
lung mycobiota and 1-month mortality
Analysis of lung mycobiota beta diversity between ARDS 1-month survivors and non-survivors
Measured: microbiota : at admission, mortality: 1 month after inclusion
bacteria and ICU mortality
Association of bacteria with ARDS ICU mortality by LefSe method
Measured: at admission
bacteria and 1-month mortality
Association of bacteria with ARDS 1-month mortality by LefSe method
Measured: microbiota : at admission, mortality: 1 month after inclusion
fungi and ICU mortality
Association of fungi with ARDS ICU mortality by LefSe method
Measured: at admission
fungi and 1-month mortality
Association of fungi with ARDS 1-month mortality by LefSe method
Measured: microbiota : at admission, mortality: 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start31 Oct 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Pauline Esteves, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133558
- Sponsor's protocol ID
- MicrA
- Acronym
- MicrA
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Lung Microbiota With Intensive Care Unit Mortality in ARDS Patients: MicrA Study
- ClinicalTrials.gov ID
- NCT04133558
- Acronym / sponsor ID
- MicrA / MicrA
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- acute respiratory distress syndrome, microbiota, intensive care unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARDS patients needing oro-tracheal intubation for mechanical ventilation in ICU
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Guardianship or curatorship
- Prisoners
- No health insurance
- No legal representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tracheal aspirate during routine caretracheal aspirate during routine care | Other | – |
Primary outcome
lung bacteriobiota and ICU mortality
Time frame: at admission
Comparison of lung bacteriobiota alpha diversity between ARDS ICU survivors and non-survivors
10 secondary outcomes
lung mycobiota and ICU mortality
Time frame: at admission
lung mycobiota and 1-month mortality
Time frame: microbiota : at admission, mortality: 1 month after inclusion
lung bacteriobiota and ICU mortality
Time frame: at admission
lung bacteriobiota and 1-month mortality
Time frame: microbiota : at admission, mortality: 1 month after inclusion
lung mycobiota and ICU mortality
Time frame: at admission
lung mycobiota and 1-month mortality
Time frame: microbiota : at admission, mortality: 1 month after inclusion
bacteria and ICU mortality
Time frame: at admission
bacteria and 1-month mortality
Time frame: microbiota : at admission, mortality: 1 month after inclusion
fungi and ICU mortality
Time frame: at admission
fungi and 1-month mortality
Time frame: microbiota : at admission, mortality: 1 month after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Distress Syndrome
Not yet recruitingObservational study
Early Switch in Moderate ARDS
Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingPhase 2
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Acute Lung Injury, Prevention
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruitingPhase 2
Fostamatinib for Treating Acute Respiratory Distress Syndrome (ARDS) in Hospitalized Adults
Acute Respiratory Distress Syndrome, ARDS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical intensive care unit, Pellegrin hospital
Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by University of Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung bacteriobiota and ICU mortality (time frame: at admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.