Trial Overview

Design

Randomised, placebo-controlled

Aims

To determine whether a 5-day course of dexamethasone, compared to placebo, started within 24 hours of admission to hospital, in addition to standard care is:

1. Associated with a lower risk of death or admission to intensive care compared to placebo (PRIMARY OBJECTIVE)
2. Associated with:
   1) a reduction in length of hospital stay
   2) the frequency of hospital readmission and/or the frequency of GP consultations after discharge

(SECONDARY OBJECTIVES)

Intervention

1. 15ml dexamethasone (6mg) once daily for 5 days started within 24 hours of admission to hospital (dose approximately equivalent to prednisolone 40 mg daily for 5 days)
2. 15ml placebo once daily for 5 days started within 24 hours of admission to hospital

Outcome Measures

Primary

• Admission to intensive care unit or death, within 30 days of admission

Secondary

• Length of stay
• Readmission within 30 days of hospital discharge
• GP consultations within 30 days of hospital discharge
• Length of stay in hospital
• Death within 30 days of admission to hospital

The full statistical plan includes the flexibility to allow for pandemics of different severity.

Population

Adults (≥16 years old) hospitalised with an influenza-like illness during a pandemic.

Eligibility

Inclusion Criteria

• Aged ≥ 16
• Admitted to hospital within the previous 24 hours with a clinical diagnosis of an influenza-like illness
• Have given consent

Exclusion Criteria

• Known to be taking oral or IV corticosteroid treatment

• Require treatment with oral or IV corticosteroids upon admission to hospital as standard treatment for comorbid illness

• Known to be on insulin or oral medication for the treatment of diabetes mellitus

• Known contra-indication to dexamethasone or any of the excipients (refer to current version of SmPC)

Duration

Recruitment is expected to last about 6 weeks.