About this trial
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.
Eligibility criteria
Qualifiers
Age ≥5 years
Decision to hospitalise
Clinical diagnosis of dengue
Severe abdominal pain or tenderness
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Placebo
- Dexamethasone
- N-Acetylcysteine
- Standard of care
- Baricitinib
Treatment groups
Sponsors and collaborators
Oxford University Clinical Research Unit, Vietnam
Lead sponsor
University of Oxford
Collaborator
The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Collaborator
Number 2 Children's Hospital, Ho Chi Minh City
Collaborator
Sukraraj Tropical and Infectious Disease Hospital, Kathmandu, Nepal
Collaborator
National Academy of Medical Sciences/Bir Hospital, Kathmandu, Nepal
Collaborator
Siriraj Hospital
Collaborator
Prince of Songkla University in Southern Thailand, Thailand
Collaborator
Dhaka Medical College
Collaborator
Chittagong Medical College Hospital, Chittagong, Bangladesh
Collaborator
Centro de Atención y Diagnóstico de Enfermedades Infecciosas, Bucaramanga, Colombia
Collaborator
Hospital Universitario Erasmo Meoz, Cucuta, Colombia
Collaborator
Fundación Valle del Lili, Cali, Colombia
Collaborator
Hospital Regional de Loreto, Iquitos, Peru
Collaborator
Instituto de Infectologia Emílio Ribas, São Paulo, Brazil
Collaborator
Universitas Sumatera Utara, Medan, Indonesia
Collaborator
Airlangga University (UNAIR), Indonesia
Collaborator
University Malaya Medical Centre, Malaysia
Collaborator
Hospital Queen Elizabeth II, Malaysia
Collaborator
San Lazaro Hospital (SLH-NU), Manila, Philippines
Collaborator