Dengue fever Infections and Infestations Dengue fever [classical dengue]
Conditions
Interventions
Suitable patients admitted to hospital within the first 3 days of fever will be randomised to receive:
1. Low dose oral prednisolone daily for 3 days (see below for details of dosage)
2. High dose ora
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 6 and 20 years, either sex 2. Weight at least 20 kg 3. Clinical suspicion of dengue, with a positive rapid test for dengue non-structural protein 1 4. Fever for less than or equal to 72 hours 5. Informed consent
Exclusion criteria
Exclusion criteria: 1. Signs or symptoms suggestive of any other acute infectious disease 2. Any evidence of significant complications of dengue, e.g., mucosal bleeding, jaundice, neurological compromise, shock, inability to tolerate oral medication 3. Any prior history of serious physical illness, or any chronic condition requiring regular follow up 4. Any history of psychiatric disorder or behaviour disturbance 5. Current or recent (within 3 months) use of any medication other than drugs for symptomatic relief (analgesics, decongestants, etc.) 6. Any history of an adverse drug reaction to any medication 7. Pregnancy (enrolment within one month of last menstrual period [LMP] in post-pubertal females)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (clinical parameters): comparison of incidence of shock, mucosal bleeding, jaundice, haematological and biochemical abnormalities in the steroid and placebo groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety (virological parameters): comparison of viral shedding in terms of viral load and NS1 clearance between the groups 2. Evaluation of the immune response to infection (cytokine profiles, microarrays) between the groups | — |
Countries
Viet Nam
Outcome results
None listed