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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT06968559
Eligibility Criteria:
Inclusion Criteria:
* 18 years old ≤ Age ≤ 80 years old.
* Total burn surface area ≥ 20%, measured by a trained expert upon admission
* Invasive mechanical ventilation at the time of inclusion
* Within 48 hours of the burn injury
* Informed and signed written consent of the next-of-kin, legal representative (trusteeship, guardianship) or emergency procedure in the absence of a legal representative.
* Affiliation with French social security system or beneficiary from such system
Exclusion Criteria:
* Imminent death and a do-not-resuscitate order
* Medical history of hypersensitivity to dexamethasone and hypersensitivity to all of its excipients
* Pregnancy (attested by a pregnancy test for women of childbearing age) and/or breastfeeding women
* Participation to another interventional study involving a drug with known interactions with dexamethasone
* Uncontrolled viral hepatitis or invasive fungal infection at the time of inclusion
* Prolonged administration of steroids in the last 90 days (\>0.3 mg/kg/day of equivalent prednisolone)
* Moderate-to-severe ARDS upon admission (according to Berlin definition criteria)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06968559
Study Brief:
Protocol Section:
NCT06968559