MedPath

Treatment of Japanese Encephalitis

Phase 2
Conditions
Japanese Encephalitis
Registration Number
NCT00216268
Lead Sponsor
Indian Council of Medical Research
Brief Summary

Japanese encephalitis is the single largest cause of viral encephalitis in the world today. It occurs in yearly post monsoon outbreaks in Uttar Pradesh and other parts of India and south east Asia. There is presently no antiviral drug of proven benefit for this illness and treatment is mostly supportive. The drug Ribavirin is already in the market in use for other indications. It has been found useful in West Nile encephalitis and various hemorrhagic fevers caused by related arboviruses. This is a double blind placebo of Ribavirin in Japanese encephalitis. To the best of our knowledge, this is the first such trial in the world. The study hypothesis is that children treated with ribavirin will be no different from those getting placebo in terms of mortality, length of hospital stay, days to return to consciousness and oral feeds, days to become afebrile and convulsion free and in 3 month sequelae rate.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
Inclusion Criteria
  • Child between 6 months and 12 years age
  • Acute febrile encephalopathy
  • Positive IgM ELISA test for Japanese encephalitis in serum
Exclusion Criteria
  • Consent not obtained

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Mortality during hospital stay
Secondary Outcome Measures
NameTimeMethod
Sequelae at 3 months
Duration of hospital stay
Days to return to oral feeds
Days to become convulsion free
Days to become afebrile

Trial Locations

Locations (1)

King George Medical University

🇮🇳

Lucknow, UP, India

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