NCT06528444

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
31mo left

Started Oct 2024

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Oct 2024Oct 2028

First Submitted

Initial submission to the registry

July 11, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

4.1 years

First QC Date

July 11, 2024

Last Update Submit

February 17, 2025

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 days

Secondary Outcomes (15)

  • The National Early Warning Score

    10 days

  • Common Terminology Criteria for Adverse Events (CTCAE) scale

    10 days

  • Rate of metabolic impact of dexamethasone

    10 days

  • the average hospital stay

    10 days

  • Number of pacients in ICU admission

    10 days

  • +10 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Grup 1 placebo

dexamethasone

ACTIVE COMPARATOR

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

Drug: Grup 2 dexametasona

Interventions

Grup 1 placeboDRUG

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

Placebo
Grup 2 dexametasonaDRUG

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

dexamethasone

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Alicante, Spain

RECRUITING

Hospital General Universitario de Elche

Elche, Spain

RECRUITING

Related Publications (1)

  • 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: 41005772DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Central Study Contacts

Javier Mateo, Biologist

CONTACT

965mateo_jav@isabial.es

Livia Giner

CONTACT

l.gineroncina@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 30, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)