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:
- Associated with a lower risk of death or admission to intensive care compared to placebo (PRIMARY OBJECTIVE)
- 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
- 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)
- 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.
This page was last updated on March 31st, 2015 at 11:31 pm