Therapeutics for Moderate and Severe Dengue
Starting soon · Phase 3 · Has a placebo group
Conditions studied: Dengue, Severe Dengue, Mosquito-Borne Diseases, Vector Borne Diseases, Arbovirus Infections, Flavivirus Infections, RNA Virus Infections, Hemorrhagic Fever
In brief
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.
Key facts
- Study ID
- NCT07543458
- Run by
- Oxford University Clinical Research Unit, Vietnam
- People needed
- 8800
- Starts
- 2026-10-01
- Expected to finish
- 2031-07-31
- Last updated by the study team
- 2026-04-21
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥5 years
- Decision to hospitalise
- Clinical diagnosis of dengue
- Participants must also have at least one of the following:
- 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
- Pulse pressure <20mmHg or hypotension for age AND at least one of: peripheral capillary refill time >2 seconds; urine output 0.5ml/kg/hr; cold/clammy peripheries; agitation or altered mental state
- Bleeding leading to hypotension for age or requiring blood transfusion or medical intervention (e.g. surgery, endoscopy, or vasoactive drugs)
- Symptomatic bleeding into a critical site (intracranial, intraspinal, intraocular with visual impairment, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome)
- Requirement for organ support, including vasopressors or inotropes, assisted ventilation, dialysis or haemofiltration, or coma (unresponsive to pain without sedation) or requirement for intravenous antiseizure medications
You may not qualify if…
- Patients on ≥ day 10 of illness or who are clinically improving in the opinion of the managing doctor (the 'recovery phase') will be excluded from recruitment. Other exclusion criteria are specific to individual treatment comparisons, and do not preclude randomisation to other arms of the study.
- A participant may not enter a specific treatment comparison if that treatment is considered to be indicated or contraindicated by the responsible clinician.
Where it is running
- Chittagong Medical College Hospital — Chittagong, Bangladesh
- Dhaka Medical College & Hospital — Dhaka, Bangladesh
- Dhaka North City Corporation Hospital — Dhaka, Bangladesh
- Instituto de Infectologia Emílio Ribas — São Paulo, Brazil
- Centro de Atención y Diagnóstico de Enfermedades Infecciosas — Bucaramanga, Colombia
- Fundación Valle del Lili — Cali, Colombia
- Hospital Universitario Erasmo Meoz — Cúcuta, Colombia
- Universitas Sumatera Utara — Medan, Indonesia
- Hospital Queen Elizabeth II, Sabah — Kota Kinabalu, Malaysia
- University Malaya Medical Centre — Kuala Lumpur, Malaysia
- National Academy of Medical Sciences/Bir Hospital — Kathmandu, Nepal
- Sukraraj Tropical and Infectious Disease Hospital — Kathmandu, Nepal
- Hospital Regional de Loreto — Iquitos, Peru
- San Lazaro Hospital — Manila, Philippines
- Siriraj Hospital, Mahidol University — Bangkok, Thailand
- Prince of Songkla University in Southern Thailand — Songkhla, Thailand
- Hospital for Tropical Diseases — Ho Chi Minh City, Vietnam
- Number 2 Children's Hospital — Ho Chi Minh City, Vietnam
Full record on ClinicalTrials.gov
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