Treatment of Japanese Encephalitis

NCT00216268 | Unknown Phase 2

• 1 other identifier: 5/8/7/1/13/2001-ECD1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (1)

• Mortality during hospital stay

Secondary Outcomes (5)

• Sequelae at 3 months

• Duration of hospital stay

• Days to return to oral feeds

• Days to become convulsion free

• Days to become afebrile

Interventions

Ribavirin DRUG

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child between 6 months and 12 years age
• Acute febrile encephalopathy
• Positive IgM ELISA test for Japanese encephalitis in serum

You may not qualify if:

• Consent not obtained

Sponsors & Collaborators

• Indian Council of Medical Research: lead

Study Sites (1)

King George Medical University

Lucknow, Uttar Pradesh, 226003, India

RECRUITING

Related Publications (1)

• 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. doi: 10.1086/596309.

  PMID: 19143532 DERIVED

MeSH Terms

Conditions

Encephalitis, Japanese

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Rashmi Kumar

  King George Medical University, Lucknow INDIA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rashmi Kumar, MD

CONTACT

91-522-2374777; rashmik2005@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2005
• Study Completion: May 1, 2008
• Last Updated: February 9, 2006

Record last verified: 2005-09

Locations

IN (1)