Treatment of Japanese Encephalitis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 2005

Last Updated Date

February 8, 2006

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Mortality during hospital stay

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00216268 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sequelae at 3 months
Duration of hospital stay
Days to return to oral feeds
Days to become convulsion free
Days to become afebrile

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of Japanese Encephalitis

Official Title ^ICMJE

Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Japanese Encephalitis

Intervention ^ICMJE

Drug: Ribavirin

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

200

Completion Date

May 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Rashmi Kumar, MD

91-522-2374777

rashmik2005@gmail.com

Location Countries ^ICMJE

India

Administrative Information

NCT ID ^ICMJE

NCT00216268

Responsible Party

Study ID Numbers ^ICMJE

5/8/7/1/13/2001-ECD1

Study Sponsor ^ICMJE

Indian Council of Medical Research

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Rashmi Kumar

King George Medical University, Lucknow INDIA

Information Provided By

Indian Council of Medical Research

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP