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:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT05138666
Eligibility Criteria:
Inclusion Criteria:
1. ICU adult patient (age \> 18 years old at inclusion)
2. Patient with respiratory distress (fever refractory to \> 3 days of antibiotherapy, pleuritic chest pain, hemoptysis) or Patient with sign of infection on thoracic scan or Patient with positive culture for Aspergillus sp on any respiratory sample
3. Informed consent signed by the patient or proxy
4. Patient with health insurance
Exclusion Criteria:
1. Minor patient (age \< 18 years old at inclusion)
2. Known risk of immunodepression as defined by EORTC/MSG:
* Recent history neutropenia (\< 500 neutrophils/mm3 for \> 10 days)
* Haematological malignancy
* Receipt of an allogenic stem cell transplant
* Receipt of a solid organ transplant
* Prolonged use of corticosteroids (excluding among patients with allergic bronchopulmonary aspergillosis) at a therapeutic dose of ≥0·3 mg/kg corticosteroids for ≥3 weeks in the past 60 days
* Treatment with recognized T-cell immunosuppressant for more than 90 days (such as calcineurin inhibitors, TNF blockers, lymphocyte-specific monoclonal antibodies, and immunosuppressive nucleoside analogues)
* Treatment with recognized inhibitors of B-cell receptor pathway (e. g, ibrutinib), possibly BCL2 inhibitors (e. g, venetoclax)
* Inherited severe immunodeficiency (e. g, chronic granulomatous disease, STAT3 deficiency, or severe combined immunodeficiency)
* Acute graft-versus-host disease grade III or IV, involving the gut, lungs, or liver, that is refractory to first-line treatment with steroids
3. Patient under legal protection (e. g, tutorship)
4. Patients without health insurance
5. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05138666
Study Brief:
Protocol Section:
NCT05138666