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NCT Number: NCT06528444

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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).
  • 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.
  • Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.
  • Patients co-infected with SARS-CoV-2 or RSV.

Treatment and study plan

Grup 1 placebo

Drug

placebo 1 capsule (6 mg) /day for 7 days.

Grup 2 dexametasona

Drug

dexamethasone 1 capsule (6 mg)/day for 7 days

Primary outcomes

  1. To compare the percentage of patients hospitalized

    Time frame: 10 days

    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.

Secondary outcomes

  1. The National Early Warning Score

    Time frame: 10 days

    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

  2. Common Terminology Criteria for Adverse Events (CTCAE) scale

    Time frame: 10 days

    To compare the frequency of serious adverse effects between groups (grades 3, 4 and 5 on the CTCAE scale).

  3. Rate of metabolic impact of dexamethasone

    Time frame: 10 days

    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.

  4. the average hospital stay

    Time frame: 10 days

    To compare the average hospital stay (expressed in days) according to treatment group.

  5. Number of pacients in ICU admission

    Time frame: 10 days

    To compare the function of occurrence over time of clinical failure, defined as progression to: need for ICU admission, need for intubation or death.

  6. mortality

    Time frame: 90 days

    To compare mortality at days 10, 30 and 90 post-randomization.

  7. the impact of treatment Barthel Index

    Time frame: 90 days

    To evaluate the impact of treatment on dependency (Barthel Index) at the time of discharge or at the end of treatment, and at 30 and 90 days after randomization.

    The final score ranges from 0 to 100, with 100 being the maximum independence and 0 being the maximum dependence.

  8. the impact of treatment Clinical Frailty Score

    Time frame: 90 days

    To evaluate the impact of treatment on frailty (Clinical Frailty Score) at the time of discharge or at the end of treatment, and at 30 and 90 days after randomization.

    . level descriptions and their corresponding labels. Most notably, CFS level 2 changed from "Well" to "Fit", level 4 from "Vulnerable" to "Living with Very Mild Frailty", and levels 5-8 were restated as "Living with..." mild, moderate, severe, and very severe frailty, respectively

  9. To evaluate the impact of steroid treatment on the evolution of the nasal microbiome expressed in alpha diversity.

    Time frame: 10 days

    To evaluate the impact of steroid treatment on the evolution of the nasal microbiome expressed in alpha diversity.

    Using NGS and then the consecutive bioinformatic analysis. More specifically, the alpha diversity would be the result of the Shannon Index and the number of ASVs (Amplicon sequence variant).

  10. the kinetics of influenza virus in nasopharyngeal swabs using Ct

    Time frame: 10 days

    To evaluate the kinetics of influenza virus in nasopharyngeal swabs (using Ct and ) in both groups.

  11. the kinetics of influenza virus in nasopharyngeal swabs using viral quantification per human cell

    Time frame: 10 days

    To evaluate the kinetics of influenza virus in nasopharyngeal swabs (viral quantification per human cell) in both groups.

  12. Evaluation inflammatory markers CRP

    Time frame: 10 days

    Evaluation the impact of treatment on inflammatory markers CRP

  13. Evaluation inflammatory markers PCT

    Time frame: 10 days

    Evaluation the impact of treatment on inflammatory markers PCT

  14. Evaluation inflammatory markers IL-6

    Time frame: 10 days

    Evaluation the impact of treatment on inflammatory markers IL-6

  15. Evaluation inflammatory markers IL-10

    Time frame: 10 days

    Evaluation the impact of treatment on inflammatory markers IL-10

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Mateo, Biologist

CONTACT

[email protected]

965 ext. 913972

Livia Giner

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria y Biomédica de Alicante

Network

Registry information

Official study title

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

Acronym: FLUDEX

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 30, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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