Clinical Trials Logo
  1. Home
  2. Japanese Encephalitis
  3. NCT00216268
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT03282370 - Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam Phase 3
Recruiting NCT05568953 - An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity Phase 2
Completed NCT00776230 - Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling Phase 3
Completed NCT00594958 - Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51 Phase 3
Completed NCT00596271 - Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440 Phase 3
Completed NCT00595790 - Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51 Phase 3
Completed NCT00604708 - Immunogenicity Study of the Japanese Encephalitis Vaccine IC51 Phase 3
Not yet recruiting NCT01954810 - Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Phase 4
Completed NCT01246479 - Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study Phase 3
Completed NCT00314132 - Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis. Phase 3
Completed NCT00605085 - Safety and Tolerability of the Japanese Encephalitis Vaccine IC51 Phase 3
Completed NCT00596102 - Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51 Phase 3
Completed NCT00595270 - Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 Phase 3
Active, not recruiting NCT01981967 - Post-licensure Safety Study of IMOJEV® in Thailand Phase 4
Completed NCT01466387 - A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults Phase 3
Completed NCT00314145 - A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX Phase 3
Completed NCT00981630 - Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine Phase 2
Completed NCT01656200 - A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2 Phase 4
Completed NCT01567865 - Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine Phase 4
Unknown status NCT01163123 - Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan N/A