A pilot study to investigate the effects of short course oral corticosteroid therapy in early dengue infection in Vietnamese patients
- Conditions
- Dengue feverInfections and InfestationsDengue fever [classical dengue]
- Registration Number
- ISRCTN39575233
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 225
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety (clinical parameters): comparison of incidence of shock, mucosal bleeding, jaundice, haematological and biochemical abnormalities in the steroid and placebo groups
- Secondary Outcome Measures
Name Time Method 1. Safety (virological parameters): comparison of viral shedding in terms of viral load and NS1 clearance between the groups<br>2. Evaluation of the immune response to infection (cytokine profiles, microarrays) between the groups