Unknown statusInterventionalPhase 3Updated Mar 1, 2023
Early Corticosteroids in Severe Influenza Pneumonia | NCT07786662 | Trialant
Not yet recruitingInterventionalPhase 3Updated Aug 26, 2026
Early Corticosteroids in Severe Influenza Pneumonia
Early Corticosteroids in Severe Influenza Pneumonia, a Phase III Randomized Controlled Trial
ClinicalTrials.gov ID
NCT07786662
Lead Sponsor
Centre Hospitalier Régional Metz-ThionvilleOTHER
Overall Status
Not yet recruiting
Study Type
Interventional
Phase
Phase 3
Enrollment
544Estimated
Last Update Posted
Aug 26, 2026Actual
Start Date
Sep 2026Estimated
Primary Completion Date
Oct 2029Estimated
Completion Date
Dec 2029Estimated
Official Title
Early Corticosteroids in Severe Influenza Pneumonia, a Phase III Randomized Controlled Trial
Brief 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. 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.
Severe Influenza
Intensive Care (ICU)
Reanimation
Infectious Diseases
Hygiene
treatment administration
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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