Early Corticosteroids in Severe Influenza Pneumonia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional Metz-Thionville
About this trial
This is a Phase III, multicentre, randomized, controlled, double-blind, superiority trial aiming to evaluate the efficacy of dexamethasone versus placebo in patients admitted to intensive care or intermediate care with influenza and hypoxemic acute respiratory failure. 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. All clinical interventions such as use of ventilatory strategy, laboratory tests, and hemodynamic management will be left at the discretion of the team in both arms. Special attention will be given to the prompt diagnosis and management of aspergillosis, with investigators provided with decision support tools and algorithms based on the most recent definition (i.e., FUNDICU). Patients will be followed for up to 28 days after enrolment and national registries will be used for 90-day vital status assessment. Telephone calls will be made on day 90 to assess quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 y
Admission to ICU or intermediate care for less than 2 days
Admission to hospital for less than 5 days
Diagnosis of influenza pneumonia with
Disqualifiers
Moribund state
Bone marrow transplant or chemotherapy-induced neutropenia
Known allergy to dexamethasone or to one of its excipients
Uncontrolled psychotic states
Trial design
Design model
Parallel
Treatments tested in this trial
Dexametasone
DrugExperimental 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.
Sodium chloride 0.9% (placebo)
DrugPlacebo : 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.
Treatment groups
544 Participants
are divided into 2 treatment groupsGroup A: DexamethasoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
At baseline and day 28Secondary outcomes
1
In-hospital death
The comparison between the two study groups of In-hospital death (all-cause)
Time frame
At day 282
Duration of extracorporeal membrane oxygenation
The comparison between the two study groups of duration of extracorporeal membrane oxygenation (ECMO) support during the study period, measured as the total number of days during which the participant receives ECMO support. Unit of Measure: Days
Time frame
At day 283
Duration of invasive mechanical ventilation
The comparaison between the two study groups of duration of invasive mechanical ventilation during the study period, measured as the total number of days during which the participant receives invasive mechanical ventilatory support. Unit of Measure: Days
Time frame
At day 284
Duration of renal replacement therapy
The comparaison between the two study groups of duration of renal replacement therapy (RRT) during the study period, measured as the total number of days during which the participant receives renal replacement therapy. Unit of Measure: Days
Time frame
At day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Régional Metz-Thionville
Lead sponsor
Henri Mondor University Hospital
Collaborator
Source ClinicalTrials.gov
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