Early Use of Dexamethasone versus Sodium Chloride Placebo in Patients with Severe Influenza-Induced Acute Hypoxemic Respiratory Failure (Phase III Randomized Trial)

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What is this study about?

This trial focuses on adults who develop severe breathing problems caused by influenza, known as influenza‑induced acute hypoxemic respiratory failure. The study compares an intravenous steroid called dexamethasone with a saline solution used as placebo. The steroid is given in a single dose shortly after the patient is admitted to the hospital.

The purpose is to find out whether the steroid improves survival and reduces the number of days patients need a ventilator or stay in the intensive care unit (ICU) during the first 28 days. Participants receive the assigned infusion early in their hospital stay and are monitored for up to three months. Researchers record outcomes such as death, the need for life‑support machines like ECMO, kidney support called renal replacement therapy, and the use of blood‑pressure‑raising drugs known as vasopressors.

Safety is closely watched for side effects including high blood sugar (hyperglycaemia), serious stomach bleeding (gastrointestinal bleeding), a lung fungal infection called pulmonary aspergillosis, and worsening infection leading to septic shock. Information is collected during the hospital stay and at follow‑up visits up to 90 days after treatment.

1 randomization and allocation

after joining the trial you are randomly assigned to receive either the active medicine or a placebo. the active medicine is dexamethasone (a corticosteroid), and the placebo is a solution of sodium chloride (common salt) that does not contain the active drug.

2 baseline assessments

initial measurements are taken, including your current health status, need for breathing support, and a swab from the inside of your nose and throat to measure the amount of influenza virus present.

these assessments provide a reference point for later comparisons.

3 study medication administration (day 0)

on the first day of the trial you receive an intravenous (into a vein) injection.

if you are in the active group, the injection contains dexamethasone phosphate at a dose of 6 mg.

if you are in the placebo group, the injection contains sodium chloride at a dose of 13.5 mg.

the exact schedule for additional doses, if any, and the total length of treatment are defined by the study protocol and are not specified in the provided information.

4 daily monitoring (day 1 to day 28)

each day you are checked for several important outcomes.

the medical team records whether you are alive, whether you need a ventilator (a machine that helps you breathe), and whether you are staying in the intensive care unit (icu).

they also monitor for safety concerns such as high blood sugar, significant bleeding in the stomach or intestines, new lung fungal infection, pneumonia acquired while on a ventilator, and any new episodes of septic shock (a severe infection causing low blood pressure).

5 follow‑up viral load samples

additional nasopharyngeal swabs are taken on day 4 and day 8 to measure how much influenza virus remains.

6 day 28 outcome assessment

on day 28 the primary results are evaluated.

the team determines whether you are alive, counts the number of days you were free from a ventilator, and counts the number of days you were free from the icu.

secondary outcomes such as organ support needs, length of hospital stay, and any adverse events that occurred up to day 28 are also recorded.

7 day 90 quality‑of‑life questionnaire

at 90 days after joining the trial you are asked to complete the sf‑36 questionnaire, which asks about your overall health and daily functioning.

8 90‑day mortality follow‑up

the final follow‑up determines whether you are alive at 90 days and records any deaths that occurred after day 28.

Who Can Join the Study?

You must be 18 years old or older.
You must have been admitted to the intensive care unit (ICU) or an intermediate care area for fewer than two days.
You must have been in the hospital for fewer than five days.
You must have a diagnosis of influenza pneumonia that includes all of the following:
- A positive PCR test for influenza taken within the past five days (PCR is a lab test that looks for the virus’s genetic material).
- Abnormal areas seen on a chest X‑ray or CT‑scan (these are imaging tests that show the lungs).
- At least one of these symptoms: coughing, coughing up pus‑filled sputum (purulent sputum), chest pain, or shortness of breath (dyspnoea).
You must need extra breathing support, which can be any one of the following:
- Supplemental oxygen at a flow rate of at least 3 L/min (extra oxygen delivered through a mask or nasal cannula).
- Non‑invasive ventilation (breathing support using a mask without a tube inside the airway).
- High flow oxygen therapy (a high‑flow device that delivers warm, humidified oxygen).
- Invasive mechanical ventilation (a breathing machine that uses a tube placed into the airway).
You must be able to give written informed consent, or if you cannot, an emergency consent must be obtained.
You must have current medical insurance coverage.

Who Cannot Join the Study?

Moribund state – being extremely close to death.
Risk of strongyloidiasis – possible infection with a type of parasitic worm that can become serious.
Shock with vasopressor therapy (≥ 0.25 µg/kg/min) – having very low blood pressure that requires medicines (vasopressors) to keep it up.
Need for high‑dose corticosteroid therapy – already requiring steroid medication at more than 0.5 mg per kg per day of a drug similar to prednisone.
Legal protective measure – being under guardianship or other legal control that prevents independent decision‑making.
Pregnant or breastfeeding woman – a woman who is expecting a baby or feeding a baby with breast milk.
Lack of clinical equipoise or high risk – the doctor does not feel the study is fair or believes participation could be unsafe.
Bone marrow transplant or chemotherapy‑induced neutropenia – having had a bone‑marrow transplant or a very low white‑blood‑cell count caused by chemotherapy.
Allergy to dexamethasone or its excipients – a known allergic reaction to the study drug or its inactive ingredients.
Uncontrolled psychotic states – severe mental illness that is not under control.
Pheochromocytoma – a rare tumor of the adrenal gland that can cause dangerous spikes in blood pressure.
Co‑infection with COVID‑19 – also infected with the coronavirus that causes COVID‑19.
Cardiogenic shock from influenza myocarditis – heart failure with very low blood pressure caused by flu‑related inflammation of the heart muscle.
Active tuberculosis or fungal infection – currently having an active TB disease or a fungal infection.
Active viral hepatitis or herpes virus infection – currently infected with hepatitis viruses or herpes viruses.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France
Groupe Hospitalier Du Sud Ile De France	Melun	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Victor Dupouy	Argenteuil	France
Centre Hospitalier De Cannes Simone Veil	Cannes	France
Centre Hospitalier De Tourcoing	Tourcoing	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospital Region Metz Thionville	Metz	France
Groupe Hospitalier Rance Emeraude	Saint-Malo	France
Centre Hospitalier Intercommunal De Poissy Saint Germain	St Germain En Laye	France
Hopital Prive Dijon Bourgogne	Dijon	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopitaux Prives De Metz	Vantoux	France
Groupe Hospitalier Bretagne Sud	Lorient	France
Centre Hospitalier De Bourg-En-Bresse	Bourg En Bresse	France
Centre Hospitalier Bretagne Atlantique	Vannes	France
Centre Medico Chirurgical Ambroise Pare Hartmann	Neuilly-Sur-Seine	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Centre Hospitalier De Haguenau	Haguenau	France
Centre Hospitalier General	Gonesse	France
Centre Hospitalier Saint Nazaire	St Nazaire	France
Centre Hospitalier Public Du Cotentin	Cherbourg-En-Cotentin	France
Hopital Nord Franche-Comte	Belfort	France
Assistance Publique Hopitaux de Paris	Creteil	France
Centre Hospital Region Metz Thionville	Thionville	France
Iebeiuci Plzehtlqbnantlr Chulkb Ctlszu	Marseille	France
Gtucxcmyhc Hximonebomy Pfsyns De Ptyhryzi	Montélimar	France
Crs dpfoekgmwfjlzz	Epagny Metz Tessy	France
Axfvoyuffg Pxdmtnca Hlouvhob Da Mezacpmtw	Marseille	France
Cmvl Dx Nnyuq	Vandoeuvre Les Nancy	France
Ceywqu Hbuhuwcwapg Vgwwago	Valence	France
Cmarxc Hoppajldewb Dz Snehlxjllgeu	Saint-Brieuc	France
Hxpmdfly Ufsigcexidyefi Stkgmzyfnd &rvtldm Hewlwun do Hoyzaoifczg	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.09.2026

Trial locations

Investigated drugs:

dexamethasone is a corticosteroid medicine that is given through a vein (intravenously) in the form of a liquid solution. In this trial, it is used to try to calm down the strong inflammatory response that can occur in the lungs of people with severe influenza pneumonia. By reducing inflammation, the drug may help improve breathing, lower the need for a ventilator, and increase the chances of surviving the illness. The study compares patients who receive this medication with those who receive a harmless saline solution, to see if dexamethasone can lead to better overall outcomes such as fewer days on a ventilator and more days spent out of the intensive care unit.

Investigated diseases:

Influenza-induced acute hypoxemic respiratory failure – This condition occurs when a severe influenza infection causes inflammation and fluid buildup in the lungs, reducing the amount of oxygen that passes into the bloodstream. Initially, patients may experience typical flu symptoms such as fever, cough, and muscle aches. As the illness progresses, breathing becomes more difficult and oxygen levels drop, leading to shortness of breath and rapid breathing. The low oxygen can cause the body to work harder to obtain enough oxygen, often resulting in the need for supplemental oxygen or breathing support. Over time, the lungs may become increasingly stiff and less able to exchange gases efficiently, worsening the respiratory difficulty.

Trial ID:

2025-524976-40-00

Protocol code:

2025-02-CHRMT

Trial Phase:

Therapeutic confirmatory (Phase III)

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Early Use of Dexamethasone versus Sodium Chloride Placebo in Patients with Severe Influenza-Induced Acute Hypoxemic Respiratory Failure (Phase III Randomized Trial)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?