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Early Corticosteroids in Severe Influenza Pneumonia, a phase III randomized controlled trial
EU CTIS ID: 2025-524976-40-00
What this study is testing
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 ICU-free days between day 0 and day 28.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- 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 • 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 3 L/min OR non-invasive ventilation OR high flow oxygen therapy OR invasive mechanical ventilation.
- Written informed or emergency consent
You likely can't join if
- Moribund state
- 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 0.5 mg/kg/day prednisone-equivalent
- Subject deprived of liberty or under a legal protective measure (example: patients under guardianship or curatorship)
- Pregnant or breastfeeding woman
See the full eligibility criteria
- Age ≥ 18 years
- 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 • 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 3 L/min OR non-invasive ventilation OR high flow oxygen therapy OR invasive mechanical ventilation.
- Written informed or emergency consent
- Ongoing medical insurance
- Moribund state
- 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 0.5 mg/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.
- 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
- Cardiogenic shock secondary to influenza myocarditis
- Known active tuberculosis or fungal infection
- Active viral hepatitis or active herpes virus infection
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.