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Can a common steroid save lives after severe burns?

NCT ID NCT06968559

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether giving the steroid dexamethasone early after a severe burn can prevent major complications like lung or kidney failure and reduce death. About 478 adults with burns covering at least 20% of their body and on a breathing machine will receive either dexamethasone or a placebo for five days. The study aims to see if calming the body's overwhelming inflammation can improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexamethasone (a corticosteroid drug)
What this could lead to
If it works, this could provide a simple, low-cost treatment to reduce organ failure and death after severe burns.
What could go wrong
This is a single Phase 3 trial; previous studies were small or retrospective. Dexamethasone may not reduce complications and could increase infections or blood sugar issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 478 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

burn

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Severe burns

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aphm Hopital La Timone

    NOT_YET_RECRUITING

    Marseille, 13005, France

  • CHR Metz

    NOT_YET_RECRUITING

    Metz, 57085, France

  • CHU Bordeaux

    NOT_YET_RECRUITING

    Pessac, 33604, France

  • CHU Lille

    NOT_YET_RECRUITING

    Lille, 59037, France

  • CHU Montpellier

    NOT_YET_RECRUITING

    Montpellier, 34295, France

  • CHU Toulouse

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • CHU Tours

    NOT_YET_RECRUITING

    Chambray-lès-Tours, 37170, France

  • CHU de Lyon

    NOT_YET_RECRUITING

    Lyon, 69437, France

  • Chu Nantes

    RECRUITING

    Nantes, 44093, France

  • HU Saint-Louis Lariboisière

    NOT_YET_RECRUITING

    Paris, 75475, France

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