Evaluating dexamethasone for severe influenza

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized, double-blind, multicenter phase III evaluation of dexamethasone's efficacy and safety compared to a placebo in patients diagnosed with severe influenza. Participants must be hospitalized and have a confirmed diagnosis of influenza A or B virus infection. The study aims to determine whether dexamethasone can improve patient outcomes in this population. The trial will involve administering either dexamethasone or a placebo to eligible patients and monitoring their recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged ≥ 18 years.
2. 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).
3. Hospitalized patients with an estimated hospital stay of more than 24 hours.
4. In previous treatment or concomitant start of treatment with oseltamivir.
5. For women of childbearing age, use of contraceptive methods until day 30 after completion of treatment.
6. Signed informed consent.

Exclusion Criteria:

* 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.

Where it's running

• Hospital General Universitario Dr. Balmis de Alicante (centro coordinador)
  Alicante, Spain Recruiting
• Hospital General Universitario de Elche
  Elche, Spain Recruiting

Study contacts

• Study coordinator: Javier Mateo, Biologist
• Email: mateo_jav@isabial.es
• Phone: 965

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.