Severe InfluenzaPhase 3ECSIPNCT07786662
Early Corticosteroids in Severe Influenza Pneumonia
A Phase 3 study testing Dexametasone in people with Severe Influenza and Intensive Care (ICU), run by Centre Hospitalier Régional Metz-Thionville at 48 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Influenza, Intensive Care (ICU), Reanimation
- What is being tested?
- Dexametasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 544 participants
- Where
- 48 sitesFrance
- Study dates
- Sep 2026to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
48 sites in 1 country. Contact the study team or a site near you to ask about taking part.
48 sites in 1 country
France48 sites
CH Argenteuil - Victor Dupouy
Argenteuil, 95107
Dr. Damien CONTOU, MD
APHP - Hôpital Avicenne
Bobigny, 93000
Pr. Stéphane GAUDRY, PUPH
CH Bourg-en-Bresse - Fleyriat
Bourg-en-Bresse, 01012
Dr. Adrien ROBINE, MD
CHU de Caen Normandie - Hôpital Côte de Nacre
Caen, 14000
Pr. Damien DU CHEYRON, MD
CH de Cannes - Simone Veil
Cannes, 06400
Dr. Nicolas CLEMENT, MD
Centre Hospitalier Public du Cotentin
Cherbourg, 50102
Dr. Xavier SOULOY, PH
APHP - Hôpital Louis Mourier
Colombes, 92700
Pr. Damien ROUX, MD
APHP - Hôpital Henri Mondor
Créteil, 94010
Pr. Nicolas DE PROST, PUPH
CHU de Dijon Bourgogne
Dijon, 21000
Pr. Jean-Pierre QUENOT, MD
CH Annecy Genevois - Site Annecy
Épagny, 74370
Dr. David BOUGON, MD
CH Joséphine Backer - Site Gonesse
Gonesse, 95503
Dr. Guillaume GELÉ-DECAUDIN, MD
CH de Haguenau
Haguenau, 67500
Dr. Asaël BERGER, MD
Centre Hospitalier Départemental Vendée - Site La Roche-Sur-Yon
La Roche-sur-Yon, 85000
Dr. Matthieu HENRY, PH
Groupe Hospitalier la Rochelle-Ré-Aunis - Hôpital de La Rochelle
La Rochelle, 17019
Dr. François PERIER, PH
CH de Versailles - Site André Mignot
Le Chesnay, 78150
Dr. Alexis FERRÉ, MD
CH Le Mans
Le Mans, 72037
Dr. Cédric DARREAU, PH
CHU de Lille - Hôpital Roger SALENGRO
Lille, 59037
Pr. Julien POISSY, PUPH
Groupe Hospitalier Bretagne Sud - Hôpital du Scorff
Lorient, 56100
Dr. Flora DELAMAIRE, PH
HCL - Hôpital de la Croix-Rousse
Lyon, 69004
Dr. Laurent BITKER, MD
HCL - Hôpital Edouard Herriot
Lyon, 69437
Pr. Laurent ARGAUD, PUPH
APHM - Hôpital de la Timone
Marseille, 13005
Dr. Julien CARVELLI, MD
Institut Paoli-Calmettes
Marseille, 13009
Dr. Djamel MOKART, MD
APHM - CHU Nord
Marseille, 13015
Pr. Sami HRAIECH, PUPH
GH Sud-Ile de France - CH de Melun-Sénart
Melun, 77000
Dr. Mehran MONCHI, MD
CHR Metz-Thionville, Hopital de Mercy
Metz, 57085
Arpiné EL NAR, projet-recherche-clinique@chr-metz-thionville.fr
Mélanie JUNKE, projet-recherche-clinique@chr-metz-thionville.fr
GH Portes de Provence - Hôpital de Montélimar
Montélimar, 26200
Dr. Pierre Yves LEGRAND, PH
CHU de Montpellier - Hôpital Saint Eloi
Montpellier, 34295
Pr. Audrey DE JONG, PUPH
CHRU de Nancy - Hôpital Central
Nancy, 54035
Pr. Sébastien GIBOT, MD
CHU de Nantes - Hôtel Dieu
Nantes, 44093
Dr. Jean-Baptiste LASCARROU, PH
Groupe Hospitalier Privé Ambroise Paré-Hartmann - Hôpital Ambroise Paré
Neuilly-sur-Seine, 92200
Dr. Guillaume GERI, MD
CHU de Nîmes - Hôpital Caremeau
Nîmes, 30029
Dr. Saber Davide BARBAR, MD
CHU d'Orléans
Orléans, 45064
Dr. Grégoire MULLER, MD
APHP - Hôpital Cochin
Paris, 75014
Pr. Frédéric PÈNE, PUPH
APHP - Groupe Hospitalier Bichat - Claude Bernard
Paris, 75877
Pr. Jean-François TIMSIT, MD
CHI de Poissy Saint-Germain-en-Laye - Site Hospitalier de Poissy
Poissy, 78300
Dr. Lionel LIMA DA SILVA, PH
CHU de Poitiers - Site de la Milétrie
Poitiers, 86021
Dr. François ARRIVÉ, MD
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
Pr. Nicolas TERZI, PUPH
CH de Saint-Brieuc, Paimpol et Tréguier - Hôpital de Saint-Brieuc
Saint-Brieuc, 22000
Dr. Thomas DOUILLARD, PH
CH de Saint-Nazaire
Saint-Nazaire, 44600
Dr. Marie-Catherine BESSE, MD
Groupe Hospitalier Rance Emeraude - Site Hospitalier Broussais
St-Malo, 35400
Dr. Éric DELAVEUVE, PH
CHRU de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67091
Dr. Julien DEMISELLE, PH
CHR Metz-Thionville, Hôpital Bel Air
Thionville, 57100
Dr. Paul DUNAND, MD
CH de Tourcoing - Hôpital Chatiliez
Tourcoing, 59208
Dr. Nicolas BOUSSEKEY, PH
Hôpital Nord Franche Comté - Site Trévenans
Trévenans, 90400
Dr. Julio BADIE, PH
CH de Valence
Valence, 26000
Dr. Tanguy DUBOST, MD
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500
Pr. Antoine KIMMOUN, PUPH
CH Bretagne Atlantique - Site Vannes
Vannes, 56000
Dr. Florian REIZINE, MD
Hôpitaux Privés de Metz - Hôpital Robert Schuman
Vantoux, 57070
Dr. Peter ESZTO, MD
About this study
Official title: Early Corticosteroids in Severe Influenza Pneumonia, a Phase III Randomized Controlled Trial
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.
Read the detailed description
Influenza virus infections cause excessive hospitalizations and deaths during seasonal peaks and pandemics. It remains a leading cause of admission to intensive care units (ICU) for acute respiratory failure. Apart from annual vaccination and other preventive measures, early administration of neuraminidase inhibitors is the only recommended treatment, but with a low level of evidence. Corticosteroids attenuate the immune response to infection and improve outcomes in patients with several types of severe pulmonary infections. Low-dose corticosteroids have been shown to reduce mortality in patients with severe COVID-19 and communityacquired pneumonia. It may also benefit critically ill patients with acute respiratory distress syndrome by reducing mortality, duration of mechanical ventilation and length of hospital stay. Observational studies with a high risk of bias have suggested an increase in mortality in patients with influenza who receive corticosteroid therapy. Others have shown a beneficial effect of corticosteroids or no link between their use and mortality. One concern for clinicians is the risk of Influenza-associated pulmonary aspergillosis (IAPA), which affects 10-20% of patients and is associated with a poor prognosis. However, there is insufficient evidence on the effects of corticosteroids administered during the ICU stay. Based on these findings and in the absence of a randomized trial, current guidelines do not recommend corticosteroid therapy in severe influenza. Therefore, a wellpowered trial is needed to test the hypothesis that corticosteroids could improve outcomes in critically-ill patients with severe influenza and acute respiratory failure.
- Being tested
- Dexametasone, Sodium chloride 0.9% (placebo)
- Keywords
- Severe Influenza, corticosteroids, acute respiratory distress syndrome, intensive care unit
- Medical subject headings
- Influenza, Human, Communicable Diseases, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexametasoneDrug
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.
Sodium chloride 0.9% (placebo)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | 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. Receives: Drug: Dexametasone |
| Placebo | Placebo comparator | 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. Receives: Drug: Sodium chloride 0.9% (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- In-hospital death (all-cause) at day 28 (yes/no),
- If alive at day 28, number of ventilator-free days between (day)
- 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.
Measured: At baseline and day 28
Secondary outcomes (12)
In-hospital death
The comparison between the two study groups of In-hospital death (all-cause)
Measured: At day 28
Duration of extracorporeal membrane oxygenation
The comparison between the two study groups of duration of extracorporeal membrane oxygenation (ECMO) support during the study period, measured as the total number of days during which the participant receives ECMO support.
Unit of Measure: Days
Measured: At day 28
Duration of invasive mechanical ventilation
The comparaison between the two study groups of duration of invasive mechanical ventilation during the study period, measured as the total number of days during which the participant receives invasive mechanical ventilatory support.
Unit of Measure: Days
Measured: At day 28
Duration of renal replacement therapy
The comparaison between the two study groups of duration of renal replacement therapy (RRT) during the study period, measured as the total number of days during which the participant receives renal replacement therapy.
Unit of Measure: Days
Measured: At day 28
Duration of vasopressor therapy
The comparaison between the two study groups of duration of vasopressor therapy during the study period, measured as the total number of days during which the participant receives vasopressor treatment.
Unit of Measure: Days
Measured: At day 28
Days alive without life support
The comparison between the two study groups of days alive without life support Number of days alive without life support (extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation (MV), renal replacement therapy (RRT) and vasopressor) (day)
Measured: At day 28
Duration of supplemental oxygen, non-invasive ventilation, high flow oxygen
The comparison between the two study groups of duration of supplemental oxygen, non-invasive ventilation, high flow oxygen.
Duration of supplemental oxygen use (Oxygen flow rate (L/min); fraction of inspired oxygen (FiO2)(%), non-invasive ventilation (FiO2)(%), high flow oxygen (FiO2)(%)
Measured: At day 28
Length of stay in hospital and ICU
Length of stay in hospital and intensive care units (ICU) (day)
Measured: At day 28 and day 90
Viral clearance
Nasopharyngeal viral load measured (IU/mL)
Measured: At baseline, day 4 and day 8
Change in quality of life
As determined with the 36-Item Short-Form Health Survey (SF-36) Questionnaire. It includes eight scales, with four measuring physical health and four assessing mental health. Each SF-36 subscale score ranges from 0 to 100, where higher scores indicate better health status
Measured: At day 90
Mortality
Assessment of mortality (yes/no)
Measured: At day 90
Safety endpoint: occurrence of adverse events
Safety endpoint: occurrence of adverse events :
- Hyperglycaemia (i.e., need for new insulin or increase in insulin >30% from initial/baseline dose) (IU)
- Clinically significant gastrointestinal bleeding (requiring endoscopy or red blood cell transfusion) (yes/no)
- Occurrence of Influenza-associated pulmonary aspergillosis (yes/no)
- Occurrence of ventilatory-acquired pneumonia (yes/no)
- New episodes of septic shock according to the Sepsis-3 criteria (yes/no)
Measured: Daily, from baseline until day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Collaborators
- Henri Mondor University Hospital
- Responsible party
- Sponsor
- Investigators
- Dr. Guillaume LOUIS, MD, Principal investigator, CHR Metz-Thionville, Hôpital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786662
- Sponsor's protocol ID
- 2025-02-CHRMT
- Acronym
- ECSIP
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Corticosteroids in Severe Influenza Pneumonia, a Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07786662
- Acronym / sponsor ID
- ECSIP / 2025-02-CHRMT
- Keywords
- Severe Influenza, corticosteroids, acute respiratory distress syndrome, intensive care unit
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Collaborators
- Henri Mondor University Hospital
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Influenza virus infections cause excessive hospitalizations and deaths during seasonal peaks and pandemics. It remains a leading cause of admission to intensive care units (ICU) for acute respiratory failure. Apart from annual vaccination and other preventive measures, early administration of neuraminidase inhibitors is the only recommended treatment, but with a low level of evidence. Corticosteroids attenuate the immune response to infection and improve outcomes in patients with several types of severe pulmonary infections. Low-dose corticosteroids have been shown to reduce mortality in patients with severe COVID-19 and communityacquired pneumonia. It may also benefit critically ill patients with acute respiratory distress syndrome by reducing mortality, duration of mechanical ventilation and length of hospital stay. Observational studies with a high risk of bias have suggested an increase in mortality in patients with influenza who receive corticosteroid therapy. Others have shown a beneficial effect of corticosteroids or no link between their use and mortality. One concern for clinicians is the risk of Influenza-associated pulmonary aspergillosis (IAPA), which affects 10-20% of patients and is associated with a poor prognosis. However, there is insufficient evidence on the effects of corticosteroids administered during the ICU stay. Based on these findings and in the absence of a randomized trial, current guidelines do not recommend corticosteroid therapy in severe influenza. Therefore, a wellpowered trial is needed to test the hypothesis that corticosteroids could improve outcomes in critically-ill patients with severe influenza and acute respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexametasonea 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 comparator | Drug: Sodium chloride 0.9% (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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
Key exclusion criteria (15 listed)
- Moribund state
- Bone marrow transplant or chemotherapy-induced neutropenia
- Known allergy to dexamethasone or to one of its excipients
- Uncontrolled psychotic states
- Pheochromocytoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexametasoneExperimental 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 | Dexamethasone |
| 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. | Drug | Placebo |
Primary outcome
Hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of ICU-free days
Time frame: At baseline and day 28
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.
12 secondary outcomes
In-hospital death
Time frame: At day 28
Duration of extracorporeal membrane oxygenation
Time frame: At day 28
Duration of invasive mechanical ventilation
Time frame: At day 28
Duration of renal replacement therapy
Time frame: At day 28
Duration of vasopressor therapy
Time frame: At day 28
Days alive without life support
Time frame: At day 28
Duration of supplemental oxygen, non-invasive ventilation, high flow oxygen
Time frame: At day 28
Length of stay in hospital and ICU
Time frame: At day 28 and day 90
Viral clearance
Time frame: At baseline, day 4 and day 8
Change in quality of life
Time frame: At day 90
Mortality
Time frame: At day 90
Safety endpoint: occurrence of adverse events
Time frame: Daily, from baseline until day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Guillaume LOUIS, MD principal investigator
CHR Metz-Thionville, Hôpital de Mercy
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexametasone in people with Severe Influenza and Intensive Care (ICU), run by Centre Hospitalier Régional Metz-Thionville at 48 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arpiné EL NAR, PhD (0033387557766, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of ICU-free days (time frame: At baseline and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.