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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 80

Early dexamethasone to lower complications and death after severe burns

Official title: Effect of Early Dexamethasone on Major Complications and All-cause Mortality in Severe Burns

Run by Nantes University Hospital · NCT06968559 · Data updated 2026-11-12

This test gives early dexamethasone or placebo to adults with severe burns who are on mechanical ventilation to see if it reduces major complications and death.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment478 (estimated)
SponsorNantes University Hospital
Academic / other
Locations10 sites (Chambray-lès-Tours and 9 other locations)
StatusRecruiting
StartedNovember 7, 2025
Main results expectedFebruary 7, 2029
Study endsFebruary 7, 2029
Registry record updatedNovember 18, 2025
Trial IDNCT06968559 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–80 with burns affecting at least 20% of total body surface area who require invasive mechanical ventilation within 48 hours of the injury and who meet French social-security and consent requirements are ideal candidates.

Probably not a fit

Patients with imminent death or do-not-resuscitate orders, known dexamethasone allergy, pregnancy or breastfeeding, uncontrolled viral hepatitis or invasive fungal infection, or those already on prolonged corticosteroids are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 randomized, placebo-controlled study comparing early dexamethasone to placebo in adults with severe burns (≥20% total body surface area) who require invasive mechanical ventilation within 48 hours of injury. Participants are randomized to receive dexamethasone or placebo and are monitored for major complications such as sepsis, ARDS, acute kidney injury, and all-cause mortality, with particular attention to events occurring in the first week. The trial is led by Nantes University Hospital with sites in Tours, Lille, and Lyon and uses next-of-kin or legal-representative consent where needed. Eligible patients must be 18–80 years old and affiliated with the French social security system.

Why it matters

Potential benefit: If successful, early dexamethasone could reduce the risk of sepsis, organ failure, and death after major burns.

How similar studies have gone: Corticosteroids have shown benefit in other acute inflammatory settings such as septic shock and ARDS, but their role in preventing early complications specifically after major burns is not yet well established.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

  • Chu Nantes
    Nantes, France     Recruiting
  • CHU Tours
    Chambray-lès-Tours, France     Not yet recruiting
  • CHU Lille
    Lille, France     Not yet recruiting
  • CHU de Lyon
    Lyon, France     Not yet recruiting
  • Aphm Hopital La Timone
    Marseille, France     Not yet recruiting
  • CHR Metz
    Metz, France     Not yet recruiting
Show 4 more locations
  • CHU Montpellier
    Montpellier, France     Not yet recruiting
  • HU Saint-Louis Lariboisière
    Paris, France     Not yet recruiting
  • CHU Bordeaux
    Pessac, France     Not yet recruiting
  • CHU Toulouse
    Toulouse, France     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.