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Early Corticosteroids in Severe Influenza Pneumonia
Sponsor: Centre Hospitalier Régional Metz-Thionville
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.
Official title: Early Corticosteroids in Severe Influenza Pneumonia, a Phase III Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
544
Start Date
2026-09
Completion Date
2029-12
Last Updated
2026-08-26
Healthy Volunteers
No
Interventions
treatment administration
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. 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.
Locations (48)
CH Argenteuil - Victor Dupouy
Argenteuil, France
APHP - Hôpital Avicenne
Bobigny, France
CH Bourg-en-Bresse - Fleyriat
Bourg-en-Bresse, France
CHU de Caen Normandie - Hôpital Côte de Nacre
Caen, France
CH de Cannes - Simone Veil
Cannes, France
Centre Hospitalier Public du Cotentin
Cherbourg, France
APHP - Hôpital Louis Mourier
Colombes, France
APHP - Hôpital Henri Mondor
Créteil, France
CHU de Dijon Bourgogne
Dijon, France
CH Annecy Genevois - Site Annecy
Épagny, France
CH Joséphine Backer - Site Gonesse
Gonesse, France
CH de Haguenau
Haguenau, France
Centre Hospitalier Départemental Vendée - Site La Roche-Sur-Yon
La Roche-sur-Yon, France
Groupe Hospitalier la Rochelle-Ré-Aunis - Hôpital de La Rochelle
La Rochelle, France
CH de Versailles - Site André Mignot
Le Chesnay, France
CH Le Mans
Le Mans, France
CHU de Lille - Hôpital Roger SALENGRO
Lille, France
Groupe Hospitalier Bretagne Sud - Hôpital du Scorff
Lorient, France
HCL - Hôpital de la Croix-Rousse
Lyon, France
HCL - Hôpital Edouard Herriot
Lyon, France
APHM - Hôpital de la Timone
Marseille, France
Institut Paoli-Calmettes
Marseille, France
APHM - CHU Nord
Marseille, France
GH Sud-Ile de France - CH de Melun-Sénart
Melun, France
CHR Metz-Thionville, Hopital de Mercy
Metz, France
GH Portes de Provence - Hôpital de Montélimar
Montélimar, France
CHU de Montpellier - Hôpital Saint Eloi
Montpellier, France
CHRU de Nancy - Hôpital Central
Nancy, France
CHU de Nantes - Hôtel Dieu
Nantes, France
Groupe Hospitalier Privé Ambroise Paré-Hartmann - Hôpital Ambroise Paré
Neuilly-sur-Seine, France
CHU de Nîmes - Hôpital Caremeau
Nîmes, France
CHU d'Orléans
Orléans, France
APHP - Hôpital Cochin
Paris, France
APHP - Groupe Hospitalier Bichat - Claude Bernard
Paris, France
CHI de Poissy Saint-Germain-en-Laye - Site Hospitalier de Poissy
Poissy, France
CHU de Poitiers - Site de la Milétrie
Poitiers, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, France
CH de Saint-Brieuc, Paimpol et Tréguier - Hôpital de Saint-Brieuc
Saint-Brieuc, France
CH de Saint-Nazaire
Saint-Nazaire, France
Groupe Hospitalier Rance Emeraude - Site Hospitalier Broussais
St-Malo, France
CHRU de Strasbourg - Hôpital de Hautepierre
Strasbourg, France
CHR Metz-Thionville, Hôpital Bel Air
Thionville, France
CH de Tourcoing - Hôpital Chatiliez
Tourcoing, France
Hôpital Nord Franche Comté - Site Trévenans
Trévenans, France
CH de Valence
Valence, France
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France
CH Bretagne Atlantique - Site Vannes
Vannes, France
Hôpitaux Privés de Metz - Hôpital Robert Schuman
Vantoux, France