Acute Respiratory Distress Syndrome (ARDS)IMMUNORESP2NCT07395076
Study of the Immunological Pathophysiological Mechanisms Associated With Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
About 10% of patients admitted to the ICU suffer from ARDS, with a mortality rate of around 35-45%. The lack of therapeutic innovation in ARDS can be partly explained by the heterogeneity of patients included under this definition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2026to 11 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Hospitalized patients in intensive care unit suffering from mechanically ventilated ARDS as defined by Matthay et al.
Who may be able to join
- ARDS risk factors: bacterial or viral pneumonia, extrapulmonary infection, major trauma, transfusion, inhalation injury, or shock.
- Pulmonary edema not explained by a cardiogenic cause or volume overload.
- Onset of respiratory symptoms within <7 days.
- Bilateral pulmonary involvement on chest X-ray, CT scan, or ultrasound.
- PaO₂/FiO₂ ≤ 300 assessed with PEEP ≥ 5 cmH₂O.
Who cannot join
- ARDS with intubation for more than 48 hours.
- Contraindications to bronchoscopy: effective anticoagulation, dual antiplatelet therapy, thrombocytopenia <50 G/L.
- Pre-existing immunodeficiency: active solid tumor or remission <5 years, active hematologic malignancy or remission <5 years, systemic disease (even without specific treatment), solid organ or bone marrow transplant, HIV infection with CD4 <200/mm³.
- Cardiac arrest with a poor prognosis (NSE >60, malignant EEG, diffuse ischemia on imaging, loss of trunk reflexes).
- Patients <18 year-old
- Patients under legal guardianship, curatorship, or deprived of liberty.
- Ongoing pregnancy.
- Patients without social security coverage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Lariboisière
Paris, 75010
Pierre-Louis BLOT, MD, 01 49 95 85 15 ext. +33, pierre-louis-blot@aphp.fr
Benjamin CHOUSTERMAN, MD, benjamin.chousterman@aphp.fr
About this study
About 10% of patients admitted to the ICU suffer from ARDS, with a mortality rate of around 35-45%. The lack of therapeutic innovation in ARDS can be partly explained by the heterogeneity of patients included under this definition.
A better understanding of the pathophysiological mechanisms underlying the different patient phenotypes is essential to develop new therapeutic strategies.
Read more
Objectives:
To characterize the inflammatory profile of patients with ARDS using circulating biomarkers and single-cell RNA sequencing of pulmonary immune cells.
The investigators hypothesize that there is a correlation between the profile of serum biomarkers (inflammatory sub-phenotypes), the transcriptome of pulmonary immune cells.
Briefly the experimental scheme is as follow:
- Population: patients with ARDS under invasive mechanical ventilation in the ICU.
- Intervention:
- Determination of the inflammatory subphenotype on circulatory inflammatory biomarkers.
- Characterization of inflammation by single cell RNA sequencing on lung immune cells collected on broncho-alveolar fluid.
Read the detailed description
Acute Respiratory Distress Syndrome (ARDS) is the most severe form of pulmonary failure. It is defined by bilateral radiologic opacities associated with severe hypoxemia, confirmed by a PaO₂/FiO₂ ratio <300 in the absence of a cardiac cause. About 10% of patients admitted to the Intensive Care Units (ICU) develop ARDS, and this diagnosis is associated with an in-hospital mortality of 35-45%. Like sepsis, ARDS leads to long-term complications. It is associated with physical deconditioning and reduced quality of life that can persist up to five years after the episode. Survivors are readmitted to the ICU within a year in 30% of cases. Moreover, excess mortality among ARDS survivors is attributable, in nearly one-third of cases, to a new acute respiratory infection.
The lack of therapeutic advances in ARDS has led researchers to better characterize patients with this condition. Different subphenotypes have been identified based on plasma inflammatory biomarker profiles, which are associated with distinct responses to treatments (such as corticosteroids, ventilatory management, and fluid management) and variable prognoses. The mechanisms underlying these different biological subphenotypes remain unknown. To further explore this concept, it is necessary to precisely identify subpopulations of patients who present with similar clinical features but distinct biological phenotypes driven by unique pathophysiological mechanisms. Establishing these different ARDS endotypes is essential for the development of innovative and targeted therapeutic strategies.
Our hypothesis is that the different biological subphenotypes of ARDS reflect distinct profiles of pulmonary immune cell populations, representing a first step toward understanding ARDS endotypes.
Identifying these endotypes is a crucial step for developing targeted and innovative therapeutic strategies aimed at reducing ARDS-related morbidity and mortality. This is the objective of the proposed project.
- Keywords
- acute respiratory distress syndrome, subphenotypes, ADRS
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Single cell RNA sequencing of pulmonary immune cells
Single cell RNA sequencing of pulmonary immune cells collected during a bronchoalveolar lavage at inclusion.
Measured: At baseline
Secondary outcomes (14)
Mortality
Mortality rate at day 90
Measured: At day 90
Mortality
Mortality rate at one year
Measured: 1 year
Time without respiratory support
Number of days alive without mechanical ventilation on day 28 after inclusion or on discharge from intensive care if this occurs before the 28th day
Measured: At day 28
Length of stay in intensive care
Number of days in intensive care.
Measured: From inclusion to ICU discharge up to 1 year
Number of secondary infections
Rate of secondary infections defined as a new prescription of antibiotics
Measured: At day 90
Number of secondary infections
Rate of secondary infections defined as a new prescription of antibiotics
Measured: 1 year
Impact perceived on quality of life
Quality of life assessed though the SF-12 questionnaire on the phone.
Measured: At day 90
Impact perceived on quality of life
Rate of secondary infections defined as a new prescription of antibiotics
Measured: 1 year
Dsypnea scale
Dyspnea scale assessed through mMRC questionnaire on the phone
Measured: At day 90
Dsypnea scale
Dyspnea scale assessed through mMRC questionnaire on the phone
Measured: 1 year
Organ failure
SOFA score assessment
Measured: At baseline
Organ failure
SOFA score assessment
Measured: At day 7.
Need for vasopressor
Need for vasopressor (epinephrine or norepinephrine)
Measured: At baseline
Vasopressor free days
Number of days alive without vasopressors on day 28 after inclusion or on discharge from intensive care if this occurs before the 28th day.
Measured: At day 28 or at discharge from intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start11 May 2026
- Primary completion11 May 2029 (estimated)
- Study completion11 May 2029 (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 Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395076
- Sponsor's protocol ID
- APHP251692
- Acronym
- IMMUNORESP2
- Status last verified
- May 2026
- First submitted
- 9 Jan 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Immunological Pathophysiological Mechanisms Associated With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07395076
- Acronym / sponsor ID
- IMMUNORESP2 / APHP251692
- Keywords
- acute respiratory distress syndrome, subphenotypes, ADRS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 11 May 2029 (estimated)
- Study completion
- 11 May 2029 (estimated)
- First posted
- 9 Feb 2026 (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.
About 10% of patients admitted to the ICU suffer from ARDS, with a mortality rate of around 35-45%. The lack of therapeutic innovation in ARDS can be partly explained by the heterogeneity of patients included under this definition.
A better understanding of the pathophysiological mechanisms underlying the different patient phenotypes is essential to develop new therapeutic strategies.
Objectives:
To characterize the inflammatory profile of patients with ARDS using circulating biomarkers and single-cell RNA sequencing of pulmonary immune cells.
The investigators hypothesize that there is a correlation between the profile of serum biomarkers (inflammatory sub-phenotypes), the transcriptome of pulmonary immune cells.
Briefly the experimental scheme is as follow:
- Population: patients with ARDS under invasive mechanical ventilation in the ICU.
- Intervention:
- Determination of the inflammatory subphenotype on circulatory inflammatory biomarkers.
- Characterization of inflammation by single cell RNA sequencing on lung immune cells collected on broncho-alveolar fluid.
Detailed description
Acute Respiratory Distress Syndrome (ARDS) is the most severe form of pulmonary failure. It is defined by bilateral radiologic opacities associated with severe hypoxemia, confirmed by a PaO₂/FiO₂ ratio <300 in the absence of a cardiac cause. About 10% of patients admitted to the Intensive Care Units (ICU) develop ARDS, and this diagnosis is associated with an in-hospital mortality of 35-45%. Like sepsis, ARDS leads to long-term complications. It is associated with physical deconditioning and reduced quality of life that can persist up to five years after the episode. Survivors are readmitted to the ICU within a year in 30% of cases. Moreover, excess mortality among ARDS survivors is attributable, in nearly one-third of cases, to a new acute respiratory infection.
The lack of therapeutic advances in ARDS has led researchers to better characterize patients with this condition. Different subphenotypes have been identified based on plasma inflammatory biomarker profiles, which are associated with distinct responses to treatments (such as corticosteroids, ventilatory management, and fluid management) and variable prognoses. The mechanisms underlying these different biological subphenotypes remain unknown. To further explore this concept, it is necessary to precisely identify subpopulations of patients who present with similar clinical features but distinct biological phenotypes driven by unique pathophysiological mechanisms. Establishing these different ARDS endotypes is essential for the development of innovative and targeted therapeutic strategies.
Our hypothesis is that the different biological subphenotypes of ARDS reflect distinct profiles of pulmonary immune cell populations, representing a first step toward understanding ARDS endotypes.
Identifying these endotypes is a crucial step for developing targeted and innovative therapeutic strategies aimed at reducing ARDS-related morbidity and mortality. This is the objective of the proposed project.
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
- Hospitalized patients in intensive care unit suffering from mechanically ventilated ARDS as defined by Matthay et al.
Key inclusion criteria (5 listed)
- ARDS risk factors: bacterial or viral pneumonia, extrapulmonary infection, major trauma, transfusion, inhalation injury, or shock.
- Pulmonary edema not explained by a cardiogenic cause or volume overload.
- Onset of respiratory symptoms within <7 days.
- Bilateral pulmonary involvement on chest X-ray, CT scan, or ultrasound.
- PaO₂/FiO₂ ≤ 300 assessed with PEEP ≥ 5 cmH₂O.
Key exclusion criteria (8 listed)
- ARDS with intubation for more than 48 hours.
- Contraindications to bronchoscopy: effective anticoagulation, dual antiplatelet therapy, thrombocytopenia <50 G/L.
- Pre-existing immunodeficiency: active solid tumor or remission <5 years, active hematologic malignancy or remission <5 years, systemic disease (even without specific treatment), solid organ or bone marrow transplant, HIV infection with CD4 <200/mm³.
- Cardiac arrest with a poor prognosis (NSE >60, malignant EEG, diffuse ischemia on imaging, loss of trunk reflexes).
- Patients <18 year-old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Single cell RNA sequencing of pulmonary immune cells
Time frame: At baseline
Single cell RNA sequencing of pulmonary immune cells collected during a bronchoalveolar lavage at inclusion.
14 secondary outcomes
Mortality
Time frame: At day 90
Mortality
Time frame: 1 year
Time without respiratory support
Time frame: At day 28
Length of stay in intensive care
Time frame: From inclusion to ICU discharge up to 1 year
Number of secondary infections
Time frame: At day 90
Number of secondary infections
Time frame: 1 year
Impact perceived on quality of life
Time frame: At day 90
Impact perceived on quality of life
Time frame: 1 year
Dsypnea scale
Time frame: At day 90
Dsypnea scale
Time frame: 1 year
Organ failure
Time frame: At baseline
Organ failure
Time frame: At day 7.
Need for vasopressor
Time frame: At baseline
Vasopressor free days
Time frame: At day 28 or at discharge from intensive care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 (ARDS), run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Louis BLOT, MD (+331049956565, pierre-louis.blot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single cell RNA sequencing of pulmonary immune cells (time frame: At baseline). 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 14 May 2026.