Adjuvant Steroids in Adults with Pandemic Influenza

Recruitment & Eligibility

Status: Active

Sex: Not specified

Target Recruitment: 2200

Inclusion Criteria

This trial will be activated in the event of a pandemic. Trial activation will be decided by the NIHR in close discussion with the Trial Steering Committee, the Chief Investigators of the 8 NIHR Pandemic Portfolio studies and the Department of Health. The following inclusion criteria will apply when the trial is activated:

During an influenza pandemic, patients are eligible for the entry into the trial if they:
1)are aged = 16 years
2)have been admitted to hospital within the previous 24 hours with a clinical diagnosis of an influenza-like illness and
3)have given consent

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

Patients are not eligible for the study if ANY of the following apply at the time of admission to hospital:
1)known to be taking oral or intravenous corticosteroid treatment
2) require treatment with oral or intravenous corticosteroids upon admission to hospital as standard treatment for comorbid illness.
3) known to be on insulin or oral medication for the treatment of diabetes mellitus
4) known contra-indication to dexamethasone or any of the excipients

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objective of the trial is to determine whether dexamethasone, given in addition to standard care reduces length of hospital stay, hospital readmission and/or post-discharge GP consultations. The trial will also evaluate cost-effectiveness of the intervention.;Primary end point(s): The primary outcome is admission to intensive care unit or death, within 30 days of admission to hospital.;Timepoint(s) of evaluation of this end point: Day 30 (Day 1 = day of hospital admission);Main Objective: To determine whether a low-dose of steroids (dexamethasone) given at the time of hospital admission for 5 days to adults hospitalised with influenza infection during a pandemic is beneficial. The primary objective of the trial will be whether dexamethasone, given in addition to standard care reduces the number of deaths or reduces the number of admissions to intensive care.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Length of stay in intensive care unit<br> 2. Readmission within 30 days of hospital discharge<br> 3. GP consultations within 30 days of hospital discharge<br> 4. Length of stay in hospital<br> 5. Death within 30 days of admission to hospital<br> 6. Admission to intensive care unit within 30 days of admission to hospital<br><br> The full statistical analysis plan for this trial includes the flexibility to allow for pandemics of different severity.<br> ;Timepoint(s) of evaluation of this end point: Length of stay will be evaluated when the patient is discharged from hospital, or at Day 60 if the patient remains hospitalised at Day 60.

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