Testing dexamethasone for hospitalised patients with dengue: A pilot clinical trial
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Background
Dengue represents a major global health challenge, with millions of infections annually and a significant proportion occurring in Asia, alongside notable ICU admission rates and mortality. Despite this burden and the recent expansion of dengue into new regions due to changing epidemiology and climate factors, treatment remains largely supportive with limited proven therapeutic options. Corticosteroids such as dexamethasone have a strong biological rationale due to their anti-inflammatory and immunomodulatory effects, potentially reducing disease severity; however, existing evidence remains inconclusive, creating clinical uncertainty and equipoise. Therefore, there is a clear need for robust clinical trials to evaluate the effectiveness of corticosteroids in improving outcomes among hospitalized dengue patients.
Aim
- To evaluate the feasibility and safety of conducting a parallel group randomized controlled trial of dexamethasone for patients hospitalized with dengue (phase 2b objective)
- To evaluate the effectiveness of dexamethasone on days alive and free of organ support at day 28 for patients hospitalised with dengue (phase 3 objective- assumes success of pilot feasibility phase)
Research methodology
This is a seamless phase 2b, multicentre, open-label randomized controlled trial conducted across 10 sites in India to evaluate the effectiveness of intravenous dexamethasone in patients hospitalized with dengue. Eligible participants will be randomly allocated to one of three groups: dexamethasone 0.1 mg/kg, dexamethasone 0.2 mg/kg, or usual care. Treatment will be administered for a maximum of 5 days, or until death or hospital discharge, whichever occurs first. Participants will be followed up on Day 28 and Day 90.
Current status
The study is currently ongoing, with six sites activated and 35 patients enrolled to date. Recruitment has been limited due to the non-dengue season; however, with the approaching dengue season, an increase in patient screening and participant enrolment is anticipated.
