Treatment of Japanese Encephalitis | RxWiki

Treatment of Japanese Encephalitis

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Japanese Encephalitis
Intervention	Drug: Ribavirin
Phase	Phase 2
Sponsor	Indian Council of Medical Research
Responsible Party	Indian Council of Medical Research
ClinicalTrials.gov Identifier	NCT00216268
First Received	September 20, 2005
Last Updated	February 8, 2006
Last verified	September 2005

Tracking Information[ + expand ][ + ]

First Received Date	September 20, 2005
Last Updated Date	February 8, 2006
Start Date	July 2005
Estimated Primary Completion Date	May 2008
Current Primary Outcome Measures	Mortality during hospital stay
Current Secondary Outcome Measures	Sequelae at 3 months Duration of hospital stay Days to return to oral feeds Days to become convulsion free Days to become afebrile

Descriptive Information[ + expand ][ + ]

Brief Title	Treatment of Japanese Encephalitis
Official Title	Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial
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 Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Condition	Japanese Encephalitis
Intervention	Drug: Ribavirin
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	200
Estimated Completion Date	May 2008
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	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
Gender	Both
Ages	6 Months
Accepts Healthy Volunteers	No
Contacts	Contact: Rashmi Kumar, MD 91-522-2374777 rashmik2005@gmail.com
Location Countries	India

Administrative Information[ + expand ][ + ]

NCT Number	NCT00216268
Other Study ID Numbers	5/8/7/1/13/2001-ECD1
Has Data Monitoring Committee	Not Provided
Information Provided By	Indian Council of Medical Research
Study Sponsor	Indian Council of Medical Research
Collaborators	Not Provided
Investigators	Principal Investigator: Rashmi Kumar King George Medical University, Lucknow INDIA
Verification Date	September 2005

Locations[ + expand ][ + ]