Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza
NCT Number: NCT06528444
Acronym: FLUDEX
Status: WITHDRAWN
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Influenza
Interventions: DRUG: Grup 1 placebo|DRUG: Grup 2 dexametasona
Sponsor: Instituto de Investigación Sanitaria y Biomédica de Alicante
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 0
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-10-31

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.

Primary Outcome Measures: 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 Outcome Measures: The National Early Warning Score, 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, 10 days|Common Terminology Criteria for Adverse Events (CTCAE) scale, To compare the frequency of serious adverse effects between groups (grades 3, 4 and 5 on the CTCAE scale)., 10 days|Rate of metabolic impact of dexamethasone, 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., 10 days|the average hospital stay, To compare the average hospital stay (expressed in days) according to treatment group., 10 days|Number of pacients in ICU admission, To compare the function of occurrence over time of clinical failure, defined as progression to: need for ICU admission, need for intubation or death., 10 days|mortality, To compare mortality at days 10, 30 and 90 post-randomization., 90 days|the impact of treatment Barthel Index, 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., 90 days|the impact of treatment Clinical Frailty Score, 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, 90 days|To evaluate the impact of steroid treatment on the evolution of the nasal microbiome expressed in alpha diversity., 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 days|the kinetics of influenza virus in nasopharyngeal swabs using Ct, To evaluate the kinetics of influenza virus in nasopharyngeal swabs (using Ct and ) in both groups., 10 days|the kinetics of influenza virus in nasopharyngeal swabs using viral quantification per human cell, To evaluate the kinetics of influenza virus in nasopharyngeal swabs (viral quantification per human cell) in both groups., 10 days|Evaluation inflammatory markers CRP, Evaluation the impact of treatment on inflammatory markers CRP, 10 days|Evaluation inflammatory markers PCT, Evaluation the impact of treatment on inflammatory markers PCT, 10 days|Evaluation inflammatory markers IL-6, Evaluation the impact of treatment on inflammatory markers IL-6, 10 days|Evaluation inflammatory markers IL-10, Evaluation the impact of treatment on inflammatory markers IL-10, 10 days