Therapeutics for Moderate and Severe Dengue

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5+
SponsorOxford University Clinical Research Unit, Vietnam

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

8,800 Participants
are divided into 3 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