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New treatment option for Severe Burns
Official title Effect of Early Dexamethasone on Major Complications and All-cause Mortality in Severe Burns
ClinicalTrials.gov ID: NCT06968559
What this study is testing
What is Dexamethasone?
Dexamethasone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for severe burns.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Burns affect more than 11 million people worldwide each year. These injuries are responsible for severe morbidity resulting in a high societal burden and account for more than 180,000 yearly deaths especially in low- and middle-income countries.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
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...
You likely can't join if
- 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 treatment 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)
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
- 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 treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- Chambray-lès-Tours, France
- Lille, France
- Lyon, France
- Marseille, France
- Metz, France
- Montpellier, France
- Nantes, France
- Paris, France
- Pessac, France
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chambray-lès-Tours, France; Lille, France; Lyon, France; Marseille, France; Metz, France; Montpellier, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.