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Early Corticosteroids in Severe Influenza Pneumonia

NCT07786662 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2026-08-28

No results posted yet for this study

Summary

This is a Phase III, multicentre, randomized, controlled, double-blind, superiority trial aiming to evaluate the efficacy of dexamethasone versus placebo in patients admitted to intensive care or intermediate care with influenza and hypoxemic acute respiratory failure. Patients will receive state-of-the-art standard therapy for severe influenza. They will be randomized in a 1:1 ratio to one of the two arms. Patients, investigators and care providers will be blinded to the patient arm. Patients will receive antiviral treatment and antibiotic therapy if bacterial co-infection is suspected. All clinical interventions such as use of ventilatory strategy, laboratory tests, and hemodynamic management will be left at the discretion of the team in both arms. Special attention will be given to the prompt diagnosis and management of aspergillosis, with investigators provided with decision support tools and algorithms based on the most recent definition (i.e., FUNDICU). Patients will be followed for up to 28 days after enrolment and national registries will be used for 90-day vital status assessment. Telephone calls will be made on day 90 to assess quality of life.

Conditions

Interventions

DRUG

Dexametasone

Experimental Group : A daily dose of 6 mg dexamethasone (investigational medicinal product) suspended in sodium chloride 0.9% and administered as a masked intravenous injection (total volume of 5 ml) once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.

DRUG

Sodium chloride 0.9% (placebo)

Placebo : A daily dose of placebo (sodium chloride 0.9%, total volume of 5 ml) intravenously once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.

Sponsors & Collaborators

  • Henri Mondor University Hospital

    collaborator OTHER

  • Centre Hospitalier Régional Metz-Thionville

    lead OTHER

Principal Investigators

  • Dr. Guillaume LOUIS, MD · CHR Metz-Thionville, Hôpital de Mercy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-10-31
Completion
2029-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07786662 on ClinicalTrials.gov