NCT07395076 Study of the Immunological Pathophysiological Mechanisms Associated With Acute Respiratory Distress Syndrome
| NCT ID | NCT07395076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Acute Respiratory Distress Syndrome (ARDS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2029-05-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-05-11 with a primary completion date of 2029-05-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07395076 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome (ARDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07395076 currently recruiting?
Yes, NCT07395076 is actively recruiting participants. Contact the research team at pierre-louis.blot@aphp.fr for enrollment information.
Where is the NCT07395076 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07395076 clinical trial?
NCT07395076 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 50 participants.