Clinical trial Recruiting at 1 site Observational Ages 18 and up

Immune mechanisms in acute respiratory distress syndrome in ventilated ICU patients.

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

Run by Assistance Publique - Hôpitaux de Paris · NCT07395076 · Data updated 2026-11-12

This project will test whether patterns of inflammatory markers in blood match gene activity of lung immune cells in adults with ARDS who are on mechanical ventilation.

More Acute Respiratory Distress Syndrome (ARDS) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Paris)
StatusRecruiting
StartedMay 11, 2026
Main results expectedMay 11, 2029
Study endsMay 11, 2029
Registry record updatedMay 14, 2026
Trial IDNCT07395076 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with ARDS of ≤7 days' onset who are on invasive mechanical ventilation with PaO2/FiO2 ≤300 (PEEP ≥5) and can safely undergo bronchoscopy are the intended participants.

Probably not a fit

Patients intubated for more than 48 hours, those with contraindications to bronchoscopy, pre-existing severe immunodeficiency, pregnancy, minors, or lacking required social coverage are unlikely to qualify or receive benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study enrolls adults with ARDS receiving invasive mechanical ventilation in the ICU and profiles circulating inflammatory biomarkers to define inflammatory subphenotypes. Investigators obtain pulmonary immune cells (likely via bronchoalveolar sampling) and perform single-cell RNA sequencing to capture cell-specific transcriptomes. They then correlate serum biomarker patterns with lung immune cell gene-expression profiles to identify distinct biological endotypes. The goal is to better understand pathophysiological mechanisms that underlie heterogeneous ARDS presentations and inform more targeted therapies.

Why it matters

Potential benefit: If successful, this work could identify biological subgroups of ARDS patients and enable more personalized treatment approaches in future trials.

How similar studies have gone: Previous studies have identified plasma inflammatory subphenotypes in ARDS linked to different outcomes and treatment responses, but combining circulating biomarkers with single-cell lung transcriptomics is a relatively new approach with limited prior results.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Hôpital Lariboisière
    Paris, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.