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Treatment of Japanese Encephalitis

NCT ID: NCT00216268

Last Updated: 2006-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-05-31

Brief Summary

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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

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Conditions

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Japanese Encephalitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ribavirin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indian Council of Medical Research

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Rashmi Kumar

Role: PRINCIPAL_INVESTIGATOR

King George Medical University, Lucknow INDIA

Locations

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King George Medical University

Lucknow, Uttar Pradesh, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Rashmi Kumar, MD

Role: CONTACT

[email protected]
91-522-2374777

Facility Contacts

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Rashmi Kumar, MD

Role: primary

[email protected]
91-522-2257377

References

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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.

Reference Type DERIVED
PMID: 19143532 (View on PubMed)

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id