Treatment of Japanese Encephalitis
Primary Purpose
Japanese Encephalitis
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Japanese Encephalitis
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
Sites / Locations
- King George Medical UniversityRecruiting
Outcomes
Primary Outcome Measures
Mortality during hospital stay
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
Full Information
NCT ID
NCT00216268
First Posted
September 20, 2005
Last Updated
February 8, 2006
Sponsor
Indian Council of Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT00216268
Brief Title
Treatment of Japanese Encephalitis
Official Title
Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Indian Council of Medical Research
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Primary Outcome Measure Information:
Title
Mortality during hospital stay
Secondary Outcome Measure Information:
Title
Sequelae at 3 months
Title
Duration of hospital stay
Title
Days to return to oral feeds
Title
Days to become convulsion free
Title
Days to become afebrile
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rashmi Kumar, MD
Phone
91-522-2374777
Email
rashmik2005@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rashmi Kumar
Organizational Affiliation
King George Medical University, Lucknow INDIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
King George Medical University
City
Lucknow
State/Province
UP
ZIP/Postal Code
226003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rashmi Kumar, MD
Phone
91-522-2257377
Email
rashmik2005@gmail.com
First Name & Middle Initial & Last Name & Degree
Rashmi Kumar, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
19143532
Citation
Kumar R, Tripathi P, Baranwal M, Singh S, Tripathi S, Banerjee G. Randomized, controlled trial of oral ribavirin for Japanese encephalitis in children in Uttar Pradesh, India. Clin Infect Dis. 2009 Feb 15;48(4):400-6. doi: 10.1086/596309.
Results Reference
derived
Learn more about this trial
Treatment of Japanese Encephalitis
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