Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
Randomized, Double-blind, Multicenter, Phase III Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
Instituto de Investigación Sanitaria y Biomédica de Alicante
42 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
Summary
Clinical trial with an active ingredient of a pharmaceutical specialty marketed in Spain vs. placebo. Randomized, double-blind, multicenter phase III clinical trial that evaluates the efficacy and safety of dexamethasone compared to placebo in patients with severe influenza.
Eligibility
Inclusion Criteria6
- Aged ≥ 18 years.
- Diagnosis of influenza A or B virus infection by antigen or RT-PCR (local laboratory) at the time of entry or at 48 hours prior to randomization in respiratory specimens (nasopharyngeal swab or bronchoalveolar lavage).
- Hospitalized patients with an estimated hospital stay of more than 24 hours.
- In previous treatment or concomitant start of treatment with oseltamivir.
- For women of childbearing age, use of contraceptive methods until day 30 after completion of treatment.
- Signed informed consent.
Exclusion Criteria5
- \. Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.
- \. Pre-inclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methyl-prednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone).
- \. Inability to administer oral oseltamivir. 4. Patients on ECMO (extracorporeal membrane oxygenation). 5. Pre-existing condition or use of medication that, in the opinion of the local investigator, may pose a risk for the administration of corticosteroids.
- \. Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.
- \. Patients co-infected with SARS-CoV-2 or RSV.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
placebo 1 capsule (6 mg) /day for 7 days.
dexamethasone 1 capsule (6 mg)/day for 7 days
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06528444