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Outcome Measures

Primary Outcomes (1)

Hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of ICU-free days
To compare the efficacy of dexamethasone versus placebo in patients with severe influenza on a hierarchical composite endpoint of all-cause mortality, number of ventilator-free days and number of Intensive Care Unit (ICU)-free days. Hierarchical composite endpoint, scored as follows: 1. In-hospital death (all-cause) at day 28 (yes/no), 2. If alive at day 28, number of ventilator-free days between (day) 3. If mechanical ventilation never required, number of ICU-free days (day) Each patient in the intervention group will be compared with each patient in the control group according to this score: a win, loss, or tie will be defined for each pair based on which scored better.
At baseline and day 28

Secondary Outcomes (12)

In-hospital death
At day 28

Study Arms (2)

Dexamethasone

EXPERIMENTAL

a daily dose of 6 mg dexamethasone (investigational medicinal product) suspended in sodium chloride 0.9% and administered as a masked intravenous injection (total volume of 5 ml) once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.

Drug: Dexametasone

Placebo

PLACEBO COMPARATOR

a daily dose of placebo (sodium chloride 0.9%, total volume of 5 ml) intravenously once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.

Drug: Sodium chloride 0.9% (placebo)

Interventions

DexametasoneDrug

Experimental Group : A daily dose of 6 mg dexamethasone (investigational medicinal product) suspended in sodium chloride 0.9% and administered as a masked intravenous injection (total volume of 5 ml) once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.

Dexamethasone

Sodium chloride 0.9% (placebo)Drug

Placebo : A daily dose of placebo (sodium chloride 0.9%, total volume of 5 ml) intravenously once daily for up to 10 days from randomization OR until discharge from the participating intensive care or intermediate care unit.

Study Sites (48)

CH Argenteuil - Victor Dupouy

Argenteuil, 95107, France

Dr. Damien CONTOU, MDPRINCIPAL INVESTIGATOR

APHP - Hôpital Avicenne

Bobigny, 93000, France

Pr. Stéphane GAUDRY, PUPHPRINCIPAL INVESTIGATOR

CH Bourg-en-Bresse - Fleyriat

Bourg-en-Bresse, 01012, France

Dr. Adrien ROBINE, MDPRINCIPAL INVESTIGATOR

CHU de Caen Normandie - Hôpital Côte de Nacre

Caen, 14000, France

Pr. Damien DU CHEYRON, MDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Influenza, HumanCommunicable DiseasesRespiratory Distress Syndrome

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases

Study Design

Study Type

interventional

Phase

phase 3

Allocation

RANDOMIZED

Masking

TRIPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR

Masking Details

Pharmacist

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Patients will receive state-of-the-art standard therapy for severe influenza. They will be randomized in a 1:1 ratio to one of the two arms. Patients, investigators and care providers will be blinded to the patient arm. Patients will receive antiviral treatment and antibiotic therapy if bacterial co-infection is suspected

Sponsor Type

OTHER

Responsible Party

SPONSOR

Early Corticosteroids in Severe Influenza Pneumonia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Dexamethasone

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (48)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Dexamethasone

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (48)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source records

Locations