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Recruiting NCT06528444

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

Phase III Interventional Influenza

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Grup 1 placebo, Grup 2 dexametasona.
Who it may be relevant to
Registry conditions: Influenza. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized, Double-blind, Multicenter, Phase III Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza

Overview

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.

Interventions

  • Drug Grup 1 placebo
    placebo 1 capsule (6 mg) /day for 7 days.
  • Drug Grup 2 dexametasona
    dexamethasone 1 capsule (6 mg)/day for 7 days

Primary outcome measures

  • To compare the percentage of patients hospitalized [Time frame: 10 days]
Secondary outcome measures (12)
  • The National Early Warning Score [Time frame: 10 days]
  • Common Terminology Criteria for Adverse Events (CTCAE) scale [Time frame: 10 days]
  • Rate of metabolic impact of dexamethasone [Time frame: 10 days]
  • the average hospital stay [Time frame: 10 days]
  • Number of pacients in ICU admission [Time frame: 10 days]
  • mortality [Time frame: 90 days]
  • the impact of treatment Barthel Index [Time frame: 90 days]
  • the impact of treatment Clinical Frailty Score [Time frame: 90 days]
  • To evaluate the impact of steroid treatment on the evolution of the nasal microbiome expressed in alpha diversity. [Time frame: 10 days]
  • the kinetics of influenza virus in nasopharyngeal swabs using Ct [Time frame: 10 days]
  • the kinetics of influenza virus in nasopharyngeal swabs using viral quantification per human cell [Time frame: 10 days]
  • Evaluation inflammatory markers CRP [Time frame: 10 days]

Eligibility criteria

Inclusion criteria

  • 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 2 centers
  • Hospital General Universitario Dr. Balmis de Alicante (centro coordinador) — Alicante
  • Hospital General Universitario de Elche — Elche

Publications

  • Ramos-RIncon JM, Cebollada J, Giner L, Paz Ventero M, Moreno-Perez O, Otero-Rodriguez S, Sanchez-Paya J, Rodriguez JC, Merino E. Efficacy and safety of dexamethasone compared to placebo in patients with severe influenza infection. (FLUDEX study): a study protocol for a randomised controlled trial in Spain. BMJ Open. 2025 Sep 26;15(9):e103119. doi: 10.1136/bmjopen-2025-103119. PMID 41005772

Identifiers

NCT: NCT06528444 · FLUDEX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗