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

Instituto de Investigación Sanitaria y Biomédica de Alicante

Status and phase: Enrolling; Phase 3

Conditions: Influenza

Treatments: Drug: Grup 1 placebo; Drug: Grup 2 dexametasona

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06528444

FLUDEX

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged ≥ 18 years.
2. 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).
3. Hospitalized patients with an estimated hospital stay of more than 24 hours.
4. In previous treatment or concomitant start of treatment with oseltamivir.
5. For women of childbearing age, use of contraceptive methods until day 30 after completion of treatment.
6. 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.

  4. Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.

  5. Patients co-infected with SARS-CoV-2 or RSV.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Grup 1 placebo

dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Grup 2 dexametasona