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 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT05280132
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old
* COPD (according to GOLD 2020), whatever the stage (I-IV)
* Acute exacerbation (defined as the onset or worsening of one or more of the usual signs/symptoms of COPD) with acute worsening of respiratory symptoms that result in additional therapy) with acute respiratory failure requiring admission to ICU and ventilatory support (invasive mechanical ventilation or non-invasive mechanical ventilation or high-flow nasal oxygen therapy with FiO2 ≥ 50%)
* Informed consent of patient, patient's immediate family/ or inclusion in an emergency situation
* Affiliation to a social security
Exclusion Criteria:
* The interval between admission to the hospital and admission to ICU more than 3 days
* Antibiotic therapy clearly needed for a suspected or documented extra-respiratory infection
* Congenital or acquired immunosuppression (congenital immune deficiency, high-grade hematologic malignancies, use of immunosuppressive drugs in the last 30 days including anti-cancer chemotherapy and antirejection medications, corticosteroid treatment ≥ 20 mg/d prednisone equivalent for at least 14 days, neutropenia, HIV with unknown or known CD4 \<200 / µL in the past 6 months)
* Tracheotomy
* Bronchiectasis / cystic fibrosis
* Moribund patient (imminent death)
* Patient deprived of liberty and / or under legal protection measure
* Patient already included in MULTI-EXA
* Patient already included in a type 1 interventional study on antibiotics
* Ongoing pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05280132
Study Brief:
Protocol Section:
NCT05280132