Not Yet RecruitingPhase 3

Therapeutics for Moderate and Severe Dengue

Bangladesh, Brazil, Colombia8,800 participantsStarted 2026-10-01

Plain-language summary

The purpose of this multi-site, factorial randomised, platform trial is to evaluate host-directed therapeutic agents in patients hospitalised with moderate and severe dengue virus infection. Our primary aim is to find safe and affordable therapeutics which prevent disease progression among those at high risk for severe dengue, and improve outcomes for those with established severe disease, thereby also reducing the substantial burden placed on health systems in dengue endemic regions.

Who can participate

Age range5 Years

SexALL

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Inclusion criteria

✓. Severe abdominal pain or tenderness
✓. Vomiting more than 3 times in the past 24 hours
✓. Pleural effusion or ascites on clinical or radiological examination
✓. Absolute haematocrit \>50%
✓. 15% increase in haematocrit compared with a baseline sample (defined as the first sample taken during the current illness)
✓. Absolute platelet count \<50 × 10⁹/L
✓. Absolute platelet count \<100 × 10⁹/L AND a drop \>50 × 10⁹/L in the past 32 hours
✓. ALT or AST \>400 IU/L

What they're measuring

Progression to severe dengue/critical dengue

Timeframe: between randomization to hospital discharge (average of 5 days)

All-cause mortality within 30 days

Timeframe: Day 30

Trial details

NCT IDNCT07543458

SponsorOxford University Clinical Research Unit, Vietnam

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-07-31

Contact for this trial

Mr. Samuel Paul

den-host@ndm.ox.ac.uk

View on ClinicalTrials.gov More Dengue trials