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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | May 11, 2026 |
| Main results expected | May 11, 2029 |
| Study ends | May 11, 2029 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07395076 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
- Study coordinator: Pierre-Louis BLOT, MD
- Email: pierre-louis.blot@aphp.fr
- Phone: +331049956565
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Understanding immune patterns and ECMO strategies to help adults with severe ARDS
This study tests how different immune and clinical patterns in adults with moderate-to-severe ARDS respond to ECMO and lung-protective care, aiming to improve outcomes.
-
Optimal corticosteroid dosing for ARDS: short vs. prolonged therapy
This trial tests different corticosteroid doses and treatment lengths to see which helps adults with ARDS who are on ventilators.
-
Lateral positioning to optimize breathing in adults after abdominal surgery with ARDS
This study tests whether lying on the left or right side helps improve lung function in adults who developed ARDS after abdominal surgery, using a bedside imaging test to watch ventilation and blood flow while changing positions.
-
Dexamethasone for sepsis-related ARDS in adults on ventilatory support
This trial tests whether dexamethasone can help adults with sepsis-associated ARDS on ventilators recover better compared to placebo.
-
NIRS for EDResp: Which first helps hypoxemic adults best?
This trial tests whether non-invasive ventilation with a mask (NIPPV) or high-flow nasal oxygen (HFNO) is more helpful for adults in the emergency department with acute hypoxemic respiratory failure.
-
Sodium bicarbonate with bedside electrical impedance tomography to map lung blood flow in ventilated adults
This project will try whether a small sodium bicarbonate injection combined with bedside electrical impedance tomography can map lung blood flow in adults on mechanical ventilation, compared with hypertonic saline.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.