Dexamethasone for dengue with warning signs
Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone
This trial will test whether dexamethasone helps people with severe dengue who have warning signs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 7 Years to 99 Years |
| Sex | All |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 2 sites (Bangkok and 1 other locations) |
| Trial ID | NCT05631405 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled trial comparing dexamethasone to placebo in patients with laboratory-confirmed dengue who remain febrile and have warning signs or early severe features. Participants are randomly assigned to receive dexamethasone or matching placebo and are monitored for shock, bleeding, fluid accumulation, respiratory distress, and organ involvement. Key exclusion criteria include severe dengue for more than 24 hours, pregnancy, and receipt of steroids within the prior week. Clinical course and safety outcomes are followed in the hospital setting at King Chulalongkorn Memorial Hospital in Bangkok.
Who should consider this trial
Good fit: Ideal candidates are people with laboratory-confirmed dengue who are still febrile and show warning signs or early severe features within 24 hours of severe illness onset, who are not pregnant and have not received steroids in the past week.
Not a fit: People with dengue without warning signs, those whose severe dengue began more than 24 hours earlier, pregnant patients, or anyone who received steroids within the previous week are unlikely to be eligible or to benefit from this trial.
Why it matters
Potential benefit: If effective, dexamethasone could reduce life-threatening complications like shock, severe bleeding, or organ failure and may shorten hospital stays.
How similar studies have performed: Previous trials of corticosteroids in dengue have been small and produced mixed or inconclusive results, so steroid treatment for dengue remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Laboratory confirmed Dengue infected patients (Positive NS1 Ag or anti-DENV IgM by Dengue Duo test) * And still in febrile phase (Body temp\>37.5 C) * Shock : Sys\<90mmHg or Narrow PP (\<20mmHg) orTachycardia (pulse\>100/min) with Hematocrit decreased ≥20 % * Fluid accumulation and respiratory distress * Severe bleeding * Severe organ involvement Exclusion Criteria: * Severe dengue\> 24 hrs * Dengue without warning signs * Pregnancy * Patient who receieved any steroid within 1 week
Where this trial is running
Bangkok and 1 other locations
- Chulalongkorn University — Bangkok, Thailand (Recruiting)
- King Chulalongkorn Memorial Hospital — Bangkok, Thailand (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.