Early Corticosteroids in Severe Influenza Pneumonia
ECSIP
1 other identifier
interventional
544
1 country
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2026
Typical duration for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2026
CompletedFirst Posted
Study publicly available on registry
August 26, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
Study Completion
Last participant's last visit for all outcomes
December 1, 2029
August 28, 2026
August 1, 2026
3.1 years
August 18, 2026
August 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of ICU-free days
To compare the efficacy of dexamethasone versus placebo in patients with severe influenza on a hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of Intensive Care Unit (ICU)-free days. Hierarchical composite endpoint, scored as follows: 1. In-hospital death (all-cause) at day 28 (yes/no), 2. If alive at day 28, number of ventilator-free days between (day) 3. If mechanical ventilation never required, number of ICU-free days (day) Each patient in the intervention group will be compared with each patient in the control group according to this score: a win, loss, or tie will be defined for each pair based on which scored better.
At baseline and day 28
Secondary Outcomes (12)
In-hospital death
At day 28
Duration of extracorporeal membrane oxygenation
At day 28
Duration of invasive mechanical ventilation
At day 28
Duration of renal replacement therapy
At day 28
Duration of vasopressor therapy
At day 28
- +7 more secondary outcomes
Study Arms (2)
Dexamethasone
EXPERIMENTALa 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
PLACEBO COMPARATORa 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 y
- Admission to ICU or intermediate care for less than 2 days
- Admission to hospital for less than 5 days
- Diagnosis of influenza pneumonia with
- PCR positive for Influenza dated less than 5 days
- AND focal shadowing/infiltrates on chest X-ray or CT-scan
- AND at least one of the following: cough, purulent sputum, chest pain or dyspnoea
- Requirement of supplemental oxygen at a flow rate of at least 3L/min OR non-invasive ventilation OR high flow oxygen therapy OR invasive mechanical ventilation
- Written informed or emergency consent
- Ongoing medical insurance
You may not qualify if:
- Moribund state
- Bone marrow transplant or chemotherapy-induced neutropenia
- Known allergy to dexamethasone or to one of its excipients
- Uncontrolled psychotic states
- Pheochromocytoma
- Co-infection with COVID-19
- Cardiogenic shock secondary to influenza myocarditis
- Known active tuberculosis or fungal infection
- Active viral hepatitis or active herpes virus infection
- Patient at risk of strongyloidiasis
- Subject with shock on enrolment and on ongoing vasopressor therapy (≥ 0.25 microg/kg/min)
- Indication for corticosteroid therapy in a dosage above 0.5mg/kg/day prednisone-equivalent
- Subject deprived of liberty or under a legal protective measure (example: patients under guardianship or curatorship)
- Pregnant or breastfeeding woman
- Lack of clinical equipoise by the attending physician and/or the presence of a substantial risk associated with the patients' participation in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
CH Argenteuil - Victor Dupouy
Argenteuil, 95107, France
APHP - Hôpital Avicenne
Bobigny, 93000, France
CH Bourg-en-Bresse - Fleyriat
Bourg-en-Bresse, 01012, France
CHU de Caen Normandie - Hôpital Côte de Nacre
Caen, 14000, France
CH de Cannes - Simone Veil
Cannes, 06400, France
Centre Hospitalier Public du Cotentin
Cherbourg, 50102, France
APHP - Hôpital Louis Mourier
Colombes, 92700, France
APHP - Hôpital Henri Mondor
Créteil, 94010, France
CHU de Dijon Bourgogne
Dijon, 21000, France
CH Annecy Genevois - Site Annecy
Épagny, 74370, France
CH Joséphine Backer - Site Gonesse
Gonesse, 95503, France
CH de Haguenau
Haguenau, 67500, France
Centre Hospitalier Départemental Vendée - Site La Roche-Sur-Yon
La Roche-sur-Yon, 85000, France
Groupe Hospitalier la Rochelle-Ré-Aunis - Hôpital de La Rochelle
La Rochelle, 17019, France
CH de Versailles - Site André Mignot
Le Chesnay, 78150, France
CH Le Mans
Le Mans, 72037, France
CHU de Lille - Hôpital Roger SALENGRO
Lille, 59037, France
Groupe Hospitalier Bretagne Sud - Hôpital du Scorff
Lorient, 56100, France
HCL - Hôpital de la Croix-Rousse
Lyon, 69004, France
HCL - Hôpital Edouard Herriot
Lyon, 69437, France
APHM - Hôpital de la Timone
Marseille, 13005, France
Institut Paoli-Calmettes
Marseille, 13009, France
APHM - CHU Nord
Marseille, 13015, France
GH Sud-Ile de France - CH de Melun-Sénart
Melun, 77000, France
CHR Metz-Thionville, Hopital de Mercy
Metz, 57085, France
GH Portes de Provence - Hôpital de Montélimar
Montélimar, 26200, France
CHU de Montpellier - Hôpital Saint Eloi
Montpellier, 34295, France
CHRU de Nancy - Hôpital Central
Nancy, 54035, France
CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
Groupe Hospitalier Privé Ambroise Paré-Hartmann - Hôpital Ambroise Paré
Neuilly-sur-Seine, 92200, France
CHU de Nîmes - Hôpital Caremeau
Nîmes, 30029, France
CHU d'Orléans
Orléans, 45064, France
APHP - Hôpital Cochin
Paris, 75014, France
APHP - Groupe Hospitalier Bichat - Claude Bernard
Paris, 75877, France
CHI de Poissy Saint-Germain-en-Laye - Site Hospitalier de Poissy
Poissy, 78300, France
CHU de Poitiers - Site de la Milétrie
Poitiers, 86021, France
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
CH de Saint-Brieuc, Paimpol et Tréguier - Hôpital de Saint-Brieuc
Saint-Brieuc, 22000, France
CH de Saint-Nazaire
Saint-Nazaire, 44600, France
Groupe Hospitalier Rance Emeraude - Site Hospitalier Broussais
St-Malo, 35400, France
CHRU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67091, France
CHR Metz-Thionville, Hôpital Bel Air
Thionville, 57100, France
CH de Tourcoing - Hôpital Chatiliez
Tourcoing, 59208, France
Hôpital Nord Franche Comté - Site Trévenans
Trévenans, 90400, France
CH de Valence
Valence, 26000, France
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500, France
CH Bretagne Atlantique - Site Vannes
Vannes, 56000, France
Hôpitaux Privés de Metz - Hôpital Robert Schuman
Vantoux, 57070, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Guillaume LOUIS, MD
CHR Metz-Thionville, Hôpital de Mercy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Pharmacist
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2026
First Posted
August 26, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
December 1, 2029
Last Updated
August 28, 2026
Record last verified: 2026-08