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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)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

12 criteria

  • 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 trial?

15 criteria

  • 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.
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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.

What is already known about the treatment

  • Dexamethasone

    This drug is given by intravenous injection as a clear liquid solution. It is an approved, widely used medication that has been studied for many years in medical literature. Dexamethasone is mainly used to reduce inflammation and suppress an over‑active immune response, such as in severe lung inflammation caused by influenza. It works by entering cells and binding to glucocorticoid receptors, which then change the activity of genes that control inflammation; it belongs to the corticosteroid (glucocorticoid) class.

  • Sodium chloride (0.9% solution)

    This placebo is administered intravenously as an infusion of sterile saline. Normal saline is an established, universally available fluid that is routinely used in hospitals and described in countless medical references. It is used to replace lost body fluids and electrolytes and to serve as a neutral carrier for other medicines in clinical studies. The solution simply adds water and salt to the bloodstream, restoring normal fluid balance, and is classified as an isotonic crystalloid electrolyte solution.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524976-40-00Protocol code2025-02-CHRMTEstimated enrolment544 patientsSponsorCentre Hospital Region Metz Thionville

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