Can a common steroid tame severe flu in the ICU?
NCT ID NCT07786662
First seen Aug 26, 2026 · Last updated Aug 28, 2026 · Updated 2 times
Summary
This phase III trial asks whether giving dexamethasone early to adults with severe influenza pneumonia and low blood oxygen can improve outcomes. Participants in intensive or intermediate care receive either the steroid or a placebo for up to 10 days, alongside standard flu treatment. The study tracks deaths, days off a ventilator, and days out of the ICU to see if the drug helps people recover faster.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexamethasone
- What this could lead to
- If effective, early dexamethasone could reduce deaths and shorten ICU stays for people with severe influenza pneumonia.
- What could go wrong
- The trial is still testing the drug; results may not confirm benefit, and corticosteroids carry risks like 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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 544 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age ≥ 18 y 2. Admission to ICU or intermediate care for less than 2 days 3. Admission to hospital for less than 5 days 4. 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 5. 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 6. Written informed or emergency consent 7. Ongoing medical insurance Exclusion Criteria: 1. Moribund state 2. Bone marrow transplant or chemotherapy-induced neutropenia 3. Known allergy to dexamethasone or to one of its excipients 4. Uncontrolled psychotic states 5. Pheochromocytoma 6. Co-infection with COVID-19 7. Cardiogenic shock secondary to influenza myocarditis 8. Known active tuberculosis or fungal infection 9. Active viral hepatitis or active herpes virus infection 10. Patient at risk of strongyloidiasis 11. Subject with shock on enrolment and on ongoing vasopressor therapy (≥ 0.25 microg/kg/min) 12. Indication for corticosteroid therapy in a dosage above 0.5mg/kg/day prednisone-equivalent 13. Subject deprived of liberty or under a legal protective measure (example: patients under guardianship or curatorship) 14. Pregnant or breastfeeding woman 15. Lack of clinical equipoise by the attending physician and/or the presence of a substantial risk associated with the patients' participation in the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
48 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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APHM - CHU Nord
Marseille, 13015, France
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APHM - Hôpital de la Timone
Marseille, 13005, France
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APHP - Groupe Hospitalier Bichat - Claude Bernard
Paris, 75877, France
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APHP - Hôpital Avicenne
Bobigny, 93000, France
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APHP - Hôpital Cochin
Paris, 75014, France
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APHP - Hôpital Henri Mondor
Créteil, 94010, France
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APHP - Hôpital Louis Mourier
Colombes, 92700, France
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CH Annecy Genevois - Site Annecy
Épagny, 74370, France
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CH Argenteuil - Victor Dupouy
Argenteuil, 95107, France
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CH Bourg-en-Bresse - Fleyriat
Bourg-en-Bresse, 01012, France
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CH Bretagne Atlantique - Site Vannes
Vannes, 56000, France
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CH Joséphine Backer - Site Gonesse
Gonesse, 95503, France
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CH Le Mans
Le Mans, 72037, France
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CH de Cannes - Simone Veil
Cannes, 06400, France
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CH de Haguenau
Haguenau, 67500, France
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CH de Saint-Brieuc, Paimpol et Tréguier - Hôpital de Saint-Brieuc
Saint-Brieuc, 22000, France
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CH de Saint-Nazaire
Saint-Nazaire, 44600, France
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CH de Tourcoing - Hôpital Chatiliez
Tourcoing, 59208, France
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CH de Valence
Valence, 26000, France
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CH de Versailles - Site André Mignot
Le Chesnay, 78150, France
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CHI de Poissy Saint-Germain-en-Laye - Site Hospitalier de Poissy
Poissy, 78300, France
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CHR Metz-Thionville, Hopital de Mercy
Metz, 57085, France
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CHR Metz-Thionville, Hôpital Bel Air
Thionville, 57100, France
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CHRU de Nancy - Hôpital Central
Nancy, 54035, France
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CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500, France
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CHRU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67091, France
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CHU d'Orléans
Orléans, 45064, France
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CHU de Caen Normandie - Hôpital Côte de Nacre
Caen, 14000, France
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CHU de Dijon Bourgogne
Dijon, 21000, France
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CHU de Lille - Hôpital Roger SALENGRO
Lille, 59037, France
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CHU de Montpellier - Hôpital Saint Eloi
Montpellier, 34295, France
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CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
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CHU de Nîmes - Hôpital Caremeau
Nîmes, 30029, France
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CHU de Poitiers - Site de la Milétrie
Poitiers, 86021, France
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CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
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Centre Hospitalier Départemental Vendée - Site La Roche-Sur-Yon
La Roche-sur-Yon, 85000, France
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Centre Hospitalier Public du Cotentin
Cherbourg, 50102, France
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GH Portes de Provence - Hôpital de Montélimar
Montélimar, 26200, France
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GH Sud-Ile de France - CH de Melun-Sénart
Melun, 77000, France
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Groupe Hospitalier Bretagne Sud - Hôpital du Scorff
Lorient, 56100, France
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Groupe Hospitalier Privé Ambroise Paré-Hartmann - Hôpital Ambroise Paré
Neuilly-sur-Seine, 92200, France
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Groupe Hospitalier Rance Emeraude - Site Hospitalier Broussais
St-Malo, 35400, France
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Groupe Hospitalier la Rochelle-Ré-Aunis - Hôpital de La Rochelle
La Rochelle, 17019, France
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HCL - Hôpital Edouard Herriot
Lyon, 69437, France
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HCL - Hôpital de la Croix-Rousse
Lyon, 69004, France
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Hôpital Nord Franche Comté - Site Trévenans
Trévenans, 90400, France
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Hôpitaux Privés de Metz - Hôpital Robert Schuman
Vantoux, 57070, France
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Institut Paoli-Calmettes
Marseille, 13009, France
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