Treatment of Japanese Encephalitis | NCT00216268

Studies
Treatment of Japanese Encephalitis

NCT00216268

Sponsor

Indian Council of Medical Research

Status

Unknown status

Last Update Posted

Feb 9, 2006Estimated

Enrollment

200

Phase

Phase 2

Conditions

Japanese Encephalitis

Interventions

Ribavirin

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

May 2008

First Submitted Date

Sep 20, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2006

Last Update Posted Date

Feb 9, 2006Estimated

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Ribavirin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality during hospital stay

Secondary Outcomes

Measure	Description	Time Frame
Sequelae at 3 months
Duration of hospital stay
Days to return to oral feeds

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rashmi Kumar, MD	Contact	91-522-2374777		rashmik2005@gmail.com

Overall Officials

Name	Affiliation	Role
Rashmi Kumar	King George Medical University, Lucknow INDIA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King George Medical University	Recruiting	Lucknow	Uttar Pradesh	226003	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19143532	Derived	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.

ID	Term
D004671	Encephalitis, Arbovirus
D018792	Encephalitis, Viral
D020805	Central Nervous System Viral Diseases
D002494	Central Nervous System Infections

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides