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Effect of early dexamethasone on major complications and all-cause mortality in severe burns
EU CTIS ID: 2024-517708-12-00
What this study is testing
To demonstrate the efficacy of dexamethasone in reducing major complications and mortality in severe burn patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Imminent death and a do-not-resuscitate order
- Pregnancy (attested by a pregnancy test for women of childbearing age) and/or breastfeeding women
- Participation to another interventional study
- Uncontrolled viral hepatitis or invasive fungal infection
- 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)
See the full eligibility 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
- Imminent death and a do-not-resuscitate order
- Pregnancy (attested by a pregnancy test for women of childbearing age) and/or breastfeeding women
- Participation to another interventional study
- Uncontrolled viral hepatitis or invasive fungal infection
- 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)
- Medical history of hypersensitivity to dexamethasone and hypersensitivity to all of its excipients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.