Can a common steroid tame severe flu in the ICU?

NCT ID NCT07786662

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 544 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    48 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • APHM - CHU Nord

    Marseille, 13015, France

  • APHM - Hôpital de la Timone

    Marseille, 13005, France

  • APHP - Groupe Hospitalier Bichat - Claude Bernard

    Paris, 75877, France

  • APHP - Hôpital Avicenne

    Bobigny, 93000, France

  • APHP - Hôpital Cochin

    Paris, 75014, France

  • APHP - Hôpital Henri Mondor

    Créteil, 94010, France

  • APHP - Hôpital Louis Mourier

    Colombes, 92700, France

  • CH Annecy Genevois - Site Annecy

    Épagny, 74370, France

  • CH Argenteuil - Victor Dupouy

    Argenteuil, 95107, France

  • CH Bourg-en-Bresse - Fleyriat

    Bourg-en-Bresse, 01012, France

  • CH Bretagne Atlantique - Site Vannes

    Vannes, 56000, France

  • CH Joséphine Backer - Site Gonesse

    Gonesse, 95503, France

  • CH Le Mans

    Le Mans, 72037, France

  • CH de Cannes - Simone Veil

    Cannes, 06400, France

  • CH de Haguenau

    Haguenau, 67500, France

  • CH de Saint-Brieuc, Paimpol et Tréguier - Hôpital de Saint-Brieuc

    Saint-Brieuc, 22000, France

  • CH de Saint-Nazaire

    Saint-Nazaire, 44600, France

  • CH de Tourcoing - Hôpital Chatiliez

    Tourcoing, 59208, France

  • CH de Valence

    Valence, 26000, France

  • CH de Versailles - Site André Mignot

    Le Chesnay, 78150, France

  • CHI de Poissy Saint-Germain-en-Laye - Site Hospitalier de Poissy

    Poissy, 78300, France

  • CHR Metz-Thionville, Hopital de Mercy

    Metz, 57085, France

  • CHR Metz-Thionville, Hôpital Bel Air

    Thionville, 57100, France

  • CHRU de Nancy - Hôpital Central

    Nancy, 54035, France

  • CHRU de Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • CHRU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67091, France

  • CHU d'Orléans

    Orléans, 45064, France

  • CHU de Caen Normandie - Hôpital Côte de Nacre

    Caen, 14000, France

  • CHU de Dijon Bourgogne

    Dijon, 21000, France

  • CHU de Lille - Hôpital Roger SALENGRO

    Lille, 59037, France

  • CHU de Montpellier - Hôpital Saint Eloi

    Montpellier, 34295, France

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093, France

  • CHU de Nîmes - Hôpital Caremeau

    Nîmes, 30029, France

  • CHU de Poitiers - Site de la Milétrie

    Poitiers, 86021, France

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • Centre Hospitalier Départemental Vendée - Site La Roche-Sur-Yon

    La Roche-sur-Yon, 85000, France

  • Centre Hospitalier Public du Cotentin

    Cherbourg, 50102, France

  • GH Portes de Provence - Hôpital de Montélimar

    Montélimar, 26200, France

  • GH Sud-Ile de France - CH de Melun-Sénart

    Melun, 77000, France

  • Groupe Hospitalier Bretagne Sud - Hôpital du Scorff

    Lorient, 56100, France

  • Groupe Hospitalier Privé Ambroise Paré-Hartmann - Hôpital Ambroise Paré

    Neuilly-sur-Seine, 92200, France

  • Groupe Hospitalier Rance Emeraude - Site Hospitalier Broussais

    St-Malo, 35400, France

  • Groupe Hospitalier la Rochelle-Ré-Aunis - Hôpital de La Rochelle

    La Rochelle, 17019, France

  • HCL - Hôpital Edouard Herriot

    Lyon, 69437, France

  • HCL - Hôpital de la Croix-Rousse

    Lyon, 69004, France

  • Hôpital Nord Franche Comté - Site Trévenans

    Trévenans, 90400, France

  • Hôpitaux Privés de Metz - Hôpital Robert Schuman

    Vantoux, 57070, France

  • Institut Paoli-Calmettes

    Marseille, 13009, France

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