A Phase 3 interventional study of Dexametasone and Sodium chloride 0.9% (placebo) in Severe Influenza, Intensive Care (ICU) and Reanimation, sponsored by Centre Hospitalier Régional Metz-Thionville. Not yet recruiting at 48 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Centre Hospitalier Régional Metz-Thionville · Phase 3, Interventional, and Treatment
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.
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.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 544 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of influenza pneumonia with
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Dexametasone
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: Sodium chloride 0.9% (placebo)
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.
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.
Time frame: At baseline and day 28
In-hospital death
The comparison between the two study groups of In-hospital death (all-cause)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)(%)
Time frame: At day 28
Length of stay in hospital and ICU
Length of stay in hospital and intensive care units (ICU) (day)
Time frame: At day 28 and day 90
Viral clearance
Nasopharyngeal viral load measured (IU/mL)
Time frame: 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
Time frame: At day 90
Mortality
Assessment of mortality (yes/no)
Time frame: At day 90
Safety endpoint: occurrence of adverse events
Safety endpoint: occurrence of adverse events : 1. Hyperglycaemia (i.e., need for new insulin or increase in insulin \>30% from initial/baseline dose) (IU) 2. Clinically significant gastrointestinal bleeding (requiring endoscopy or red blood cell transfusion) (yes/no) 3. Occurrence of Influenza-associated pulmonary aspergillosis (yes/no) 4. Occurrence of ventilatory-acquired pneumonia (yes/no) 5. New episodes of septic shock according to the Sepsis-3 criteria (yes/no)
Time frame: Daily, from baseline until day 28
Start is estimated for Sep 2026; primary completion for Oct 2029, 37 months later.
Of 35 non-industry phase 3 interventional studies under Influenza, Human, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 41. This study's planned 37 months is above that.
Counting every sponsor, half of 153 studies reached it within 8 months; a quarter within 4 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
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