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Treatment of Japanese Encephalitis

This study is currently recruiting participants.
Verified by Indian Council of Medical Research, September 2005

Sponsored by: Indian Council of Medical Research
Information provided by: Indian Council of Medical Research
ClinicalTrials.gov Identifier: NCT00216268
  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 Intervention Phase
Japanese Encephalitis
Drug: Ribavirin
Phase II

MedlinePlus related topics:   Encephalitis   

ChemIDplus related topics:   Ribavirin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial

Further study details as provided by Indian Council of Medical Research:

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

Estimated Enrollment:   200
Study Start Date:   July 2005
Estimated Study Completion Date:   May 2008

  Eligibility
Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216268

Contacts
Contact: Rashmi Kumar, MD     91-522-2374777     rashmik2005@gmail.com    

Locations
India, UP
King George Medical University     Recruiting
      Lucknow, UP, India, 226003
      Contact: Rashmi Kumar, MD     91-522-2257377     rashmik2005@gmail.com    
      Principal Investigator: Rashmi Kumar, MD            

Sponsors and Collaborators
Indian Council of Medical Research

Investigators
Principal Investigator:     Rashmi Kumar     King George Medical University, Lucknow INDIA    
  More Information

Study ID Numbers:   5/8/7/1/13/2001-ECD1
First Received:   September 20, 2005
Last Updated:   February 8, 2006
ClinicalTrials.gov Identifier:   NCT00216268
Health Authority:   India: Ministry of Health

Study placed in the following topic categories:
Virus Diseases
Japanese encephalitis
Central Nervous System Infections
Ribavirin
Central Nervous System Diseases
Encephalitis, Japanese
Arbovirus Infections
Brain Diseases
Encephalitis

Additional relevant MeSH terms:
Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on September 04, 2008




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