Status:
RECRUITING
Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
Lead Sponsor:
Instituto de Investigación Sanitaria y Biomédica de Alicante
Conditions:
Influenza
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief 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 sa...
Eligibility Criteria
Inclusion
- 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
- 1\. Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.
- 2\. 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).
- 3\. 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.
- 6\. Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.
- 7\. Patients co-infected with SARS-CoV-2 or RSV.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06528444
Start Date
October 1 2024
End Date
October 31 2028
Last Update
February 19 2025
Active Locations (2)
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1
Hospital General Universitario Dr. Balmis de Alicante (centro coordinador)
Alicante, Spain
2
Hospital General Universitario de Elche
Elche, Spain