Clinical trial NCT06528444: Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Instituto de Investigación Sanitaria y Biomédica de Alicante
Sponsor class: NETWORK
First posted: 2024-07-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

  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.

Primary outcomes:
measure: To compare the percentage of patients hospitalized
timeFrame: 10 days
Secondary outcomes:
measure: The National Early Warning Score
timeFrame: 10 days
measure: Common Terminology Criteria for Adverse Events (CTCAE) scale
timeFrame: 10 days
measure: Rate of metabolic impact of dexamethasone
timeFrame: 10 days
measure: the average hospital stay
timeFrame: 10 days
measure: Number of pacients in ICU admission
timeFrame: 10 days
measure: mortality
timeFrame: 90 days
measure: the impact of treatment Barthel Index
timeFrame: 90 days
measure: the impact of treatment Clinical Frailty Score
timeFrame: 90 days
measure: To evaluate the impact of steroid treatment on the evolution of the nasal microbiome expressed in alpha diversity.
timeFrame: 10 days
measure: the kinetics of influenza virus in nasopharyngeal swabs using Ct
timeFrame: 10 days
measure: the kinetics of influenza virus in nasopharyngeal swabs using viral quantification per human cell
timeFrame: 10 days
measure: Evaluation inflammatory markers CRP
timeFrame: 10 days
measure: Evaluation inflammatory markers PCT
timeFrame: 10 days
measure: Evaluation inflammatory markers IL-6
timeFrame: 10 days
measure: Evaluation inflammatory markers IL-10
timeFrame: 10 days
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis de Alicante (centro coordinador)
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
Study officials:
References: