Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza

ConditionInfluenza
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorInstituto de Investigación Sanitaria y Biomédica de Alicante

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

1. Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.

Trial design

Treatments tested in this trial

  • Grup 1 placebo
  • Grup 2 dexametasona

Treatment groups

42 Participants
are divided into 2 treatment groups