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NCT00216268 Clinical Trial

Treatment of Japanese Encephalitis

Japanese Encephalitis Clinical Trial

Official title:
Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00216268
Other study ID # 5/8/7/1/13/2001-ECD1
Secondary ID
Status Recruiting
Phase Phase 2
First received September 20, 2005
Last updated February 8, 2006
Start date July 2005
Est. completion date May 2008

Study information
Verified date September 2005
Source Indian Council of Medical Research
Contact Rashmi Kumar, MD
Phone 91-522-2374777
Email rashmik2005@gmail.com
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date May 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 12 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ribavirin

Locations
Country Name City State
India King George Medical University Lucknow UP

Sponsors (1)
Lead Sponsor Collaborator
Indian Council of Medical Research

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality during hospital stay
Secondary Sequelae at 3 months
Secondary Duration of hospital stay
Secondary Days to return to oral feeds
Secondary Days to become convulsion free
Secondary Days to become afebrile
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