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.
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.
1. Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.
Parallel
Grup 1 placebo
Drugplacebo 1 capsule (6 mg) /day for 7 days.
Grup 2 dexametasona
Drugdexamethasone 1 capsule (6 mg)/day for 7 days
To compare the percentage of patients hospitalized
To compare the percentage of patients hospitalized with influenza according to treatment arm (oseltamivir-dexamethasone vs oseltamivir-placebo) with status 3 or higher according to the Hospital Recovery Scale (status 3: hospitalization with supplemental oxygen, or 4: ICU admission without invasive mechanical ventilation, or 5: with invasive mechanical ventilation, or 6: death) on day 7 after the start of treatment.
The National Early Warning Score
To compare the time, in days, between initiation of treatment and clinical stability according to the NEWS2\<2 scale for 24 hours or until hospital discharge, taking the value of the first of the two events to occur
Common Terminology Criteria for Adverse Events (CTCAE) scale
To compare the frequency of serious adverse effects between groups (grades 3, 4 and 5 on the CTCAE scale).
Rate of metabolic impact of dexamethasone
To evaluate the metabolic impact of dexamethasone by comparing the function of occurrence of sustained hyperglycemia level 1 and 2, and episodes of hyperglycemia during and at the end of dexamethasone treatment.
the average hospital stay
To compare the average hospital stay (expressed in days) according to treatment group.
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