Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT03971006
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Affiliated to a social security system
* Patient informed and have given his non opposition verbally (trustworthy or a family member non opposition is required if the patient is unable to give his non opposition)
Groupe 1 :
\- Patient with ARDS secondary to pneumonia defined by following criteria: Intubation and mechanical ventilation for less than 48 hours Lung infection evolving since less than 7 days Bilateral pulmonary radiological opacities compatible with edema pulmonary lesion PaO2 / FiO2 ratio ≤ 300 mmHg with a positive expiratory pressure level ≥ 5 cmH2O
\- Absence of immunosuppression (No HIV infection, bone marrow or solid organ transplantation, post-chemotherapy aplasia, immunosuppressive therapy or corticosteroid therapy (\>200 mg / day of hydrocortisone or equivalent in the 4 weeks prior to inclusion))
Group 2 - Patient with ARDS secondary to pneumonia defined by following criteria: Intubation and mechanical ventilation for less than 48 hours Lung infection evolving since less than 7 days Bilateral pulmonary radiological opacities compatible with edema pulmonary lesion PaO2 / FiO2 ratio ≤ 300 mmHg with a positive expiratory pressure level ≥ 5 cmH2O
\- Previously known immunosuppression (patient with HIV, solid tumor, solid organ transplantation or under corticosteroids therapy since at least 4 weeks before inclusion)
Group 3
* LBA indicated in usual care
* Absence of ARDS
* Absence of evolutionary infection
* Absence of infiltrative lung disease
* Absence of immunosuppression (No HIV infection, bone marrow or solid organ transplantation, post-chemotherapy aplasia, immunosuppressive therapy, corticosteroid therapy (\> 200 mg / day of hydrocortisone or equivalent in the 4 weeks prior to inclusion))
Exclusion Criteria:
* Chronic respiratory insufficiency treated by long-term oxygen therapy and / or long-term respiratory assistance
* Child-Pugh C cirrhosis
* Pulmonary fibrosis
* Active lymphoid and myeloid malignant hemopathies
* Neutropenia (neutrophils \<1500 / mm3)
* Patient moribund the day of inclusion or having an IGS II score greater than 90
* Irreversible neurological pathology: cerebral involvement, encephalic death
* Decision to limit active therapies
* Deep hypoxemia (PaO2 / FiO2 \<75 mmHg)
* Patient protected by law
* Pregnant or lactating woman
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03971006
Study Brief:
Protocol Section:
NCT03971006