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

NCT07395076 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Observational

Started

2026-05-11

Last updated

2026-05-14

Condition(s) studied

Acute Respiratory Distress Syndrome (ARDS)

Study 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:

1. Determination of the inflammatory subphenotype on circulatory inflammatory biomarkers.
2. Characterization of inflammation by single cell RNA sequencing on lung immune cells collected on broncho-alveolar fluid.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Hôpital Lariboisière	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07395076 on ClinicalTrials.gov ↗ ← All trials in France