Treatment of Japanese Encephalitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Indian Council of Medical Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Indian Council of Medical Research
ClinicalTrials.gov Identifier:
NCT00216268
First received: September 20, 2005
Last updated: February 8, 2006
Last verified: September 2005
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial

Resource links provided by NLM:


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
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

No publications provided by Indian Council of Medical Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00216268     History of Changes
Other Study ID Numbers: 5/8/7/1/13/2001-ECD1
Study First Received: September 20, 2005
Last Updated: February 8, 2006
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Encephalitis, Arbovirus
Encephalitis, Viral
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 20, 2014