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
  3. (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

Secondary

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

Exclusion Criteria

Duration

Recruitment is expected to last about 6 weeks.

This page was last updated on March 31st, 2015 at 11:31 pm


This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 12/127/10). Trial Identifier: ISRCTN72331452. EudraCT Number: 2013-001051-12.