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Treatment of Japanese Encephalitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00216268
Recruitment Status : Unknown
Verified September 2005 by Indian Council of Medical Research.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : February 9, 2006
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Drug: Ribavirin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial
Study Start Date : July 2005
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
Drug Information available for: Ribavirin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Mortality during hospital stay

Secondary Outcome Measures :
  1. Sequelae at 3 months
  2. Duration of hospital stay
  3. Days to return to oral feeds
  4. Days to become convulsion free
  5. Days to become afebrile

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 9, 2006
Last Verified: September 2005

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