Actively Recruiting
Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone
Led by Chulalongkorn University · Updated on 2025-08-07
200
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether steroid therapy with dexamethasone may be effective for treating severe dengue infection in patients who show warning signs. This randomized, double-blind, placebo-controlled trial focuses on understanding the impact of dexamethasone on mortality and other health outcomes in this population. The study is sponsored by Chulalongkorn University and includes participants aged 7 to 99 years. Participants are randomly assigned to receive either dexamethasone or a placebo. The trial uses a quadruple masking design, ensuring that participants, care providers, investigators, and outcomes assessors are unaware of the group assignments. The study aims to compare the effects of dexamethasone treatment against placebo in those with severe dengue during the febrile phase. During the study, researchers will monitor participants for mortality over 28 days as the primary outcome. Secondary outcomes include the length of hospital stay within the same period. Screening includes laboratory confirmation of dengue infection and assessments of fever, shock signs, fluid accumulation, bleeding, and organ involvement. The total participation time varies depending on individual hospital stays and clinical progress, with close safety monitoring throughout the trial.
CONDITIONS
Brief Title
Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone (DengDex Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Laboratory confirmed Dengue infected patients (Positive NS1 Ag or anti-DENV IgM by Dengue Duo test)
- Currently in febrile phase with body temperature above 37.5°C
- Signs of shock such as systolic blood pressure below 90 mmHg, narrow pulse pressure less than 20 mmHg, or tachycardia with pulse above 100/min and hematocrit decrease of 20% or more
- Presence of fluid accumulation and respiratory distress
- Severe bleeding
- Severe organ involvement
You will not qualify if you...
- Severe dengue for more than 24 hours
- Dengue without warning signs
- Pregnancy
- Steroid use within the past week
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive either dexamethasone or placebo to treat dengue infection with warning signs.
Daily visits during hospitalization up to 28 days
Duration - Up to 28 days
Participants are monitored for health outcomes including mortality and length of hospital stay after treatment.
Follow-up visits as needed up to 28 days
Trial Site Locations
Total: 2 locations
1
Chulalongkorn University
Bangkok, Thailand
Actively Recruiting
2
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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