Study of the Immunological Pathophysiological Mechanisms Associated With Acute Respiratory Distress Syndrome

NCT07395076 | Recruiting

• 1 other identifier: APHP251692
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

acute respiratory distress syndrome; subphenotypes; ADRS

Outcome Measures

Primary Outcomes (1)

• Single cell RNA sequencing of pulmonary immune cells

  Single cell RNA sequencing of pulmonary immune cells collected during a bronchoalveolar lavage at inclusion.

  At baseline

Secondary Outcomes (14)

• Mortality

  At day 90

• Mortality

  1 year

• Time without respiratory support

  At day 28

• Length of stay in intensive care

  From inclusion to ICU discharge up to 1 year

• Number of secondary infections

  At day 90

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients in intensive care unit suffering from mechanically ventilated ARDS as defined by Matthay et al.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Lariboisière

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Pierre-Louis BLOT, MD

CONTACT

+331049956565; pierre-louis.blot@aphp.fr

Benjamin Chousterman, MD PhD

CONTACT

+330149958518; benjamin.chousterman@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: February 9, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): May 11, 2029
• Study Completion (Estimated): May 11, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

FR (1)