Effect of early dexamethasone on major complications and all-cause mortality in severe burns

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nantes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

7 Nov 2025 → ongoing

Decision date (initial)

2025-04-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

PHRC-N

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To demonstrate the efficacy of dexamethasone in reducing major complications and mortality in severe burn patients.

Secondary objectives 7

1. Demonstrate the efficacy of dexamethasone in reducing the rates of hospital-acquired infections (i.e pneumonia, catheter-related bloodstream infections, other infections) and antibiotic-free days
2. Demonstrate the efficacy of dexamethasone in decreasing respiratory complications and increasing ventilator-free days
3. To study the impact of dexamethasone on ICU Length-of-Stay and Hospital Length-of-Stay and risks of organ dysfunction
4. To study the general tolerance of the treatment: hyperglycemia, hypernatremia, hypokalaemia
5. To study the specific tolerance of the treatment on skin lesions (surgical site infections, autograft failures)
6. To study the impact of treatment on serum CRP levels
7. To study the impact of the timing of first surgery on the main endpoint

Conditions and MedDRA coding

Severe burns

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 18 years old ≤ Age ≤ 80 years old.
2. Total burn surface area ≥ 20%, measured by a trained expert upon admission
3. Invasive mechanical ventilation at the time of inclusion
4. Within 48 hours of the burn injury
5. Informed and signed written consent of the next-of-kin, legal representative (trusteeship, guardianship) or emergency procedure in the absence of a legal representative.
6. Affiliation with French social security system or beneficiary from such system

Exclusion criteria 7

1. Imminent death and a do-not-resuscitate order
2. Pregnancy (attested by a pregnancy test for women of childbearing age) and/or breastfeeding women
3. Participation to another interventional study
4. Uncontrolled viral hepatitis or invasive fungal infection
5. Prolonged administration of steroids in the last 90 days (>0.3 mg/kg/day of equivalent prednisolone)
6. Moderate-to-severe ARDS upon admission (according to Berlin definition criteria)
7. Medical history of hypersensitivity to dexamethasone and hypersensitivity to all of its excipients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Hierarchical endpoints: - Major complications defined as moderate to severe ARDS (using Berlin definition criteria) or AKI KDIGO 2 to 3 within 28 days - All-cause mortality at day 90 On the basis of a hierarchical testing plan, the primary endpoints will be tested sequentially for superiority. First we will test for superiority on major complications. If positive, we will test for superiority on all-cause mortality.

Secondary endpoints 7

1. Hospital-acquired infections: ● Hospital-acquired pneumonia (using the joint definition from the Infectious Diseases Society of America and American Thoracic Society) within 28 days ● Catheter-related bloodstream infections within 28 days ● other infections, including skin infections (diagnosis confirmed by an independent adjudication committee) with or without bacteraemia within 28 days ● Antibiotic-free days on day 28
2. Respiratory complications: ● ARDS (using Berlin Criteria definition) on day 28 ● Invasive ventilator-free days on day 28
3. ICU LOS and Hospital LOS, SOFA scores on day 1, day 3, day 7 and day 14, KDIGO stages 2 and 3 AKI within 28 days
4. General tolerance within day 28: ● hyperglycemia, ● hypernatremia, ● hypokalaemia, ● gastrointestinal bleeding, ● acquired-weakness
5. Specific tolerance within 28 days: ● surgical site infections confirmed by an independent adjudication committee, ● autograft failures
6. Serum CRP levels on day 0, day 1, day 3, day 7 and day 14
7. Timing of first surgery

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation

Centre Hospitalier Universitaire De Nantes

Address

5 Allee De L Ile Gloriette, Cs 69301 Cs 69301

City

Nantes Cedex 1

Postcode

44093

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

ASEHNOUNE Karim

Public contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

ASEHNOUNE Karim

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications