Japanese EncephalitisPhase 2NCT00216268
Treatment of Japanese Encephalitis
A Phase 2 study testing Ribavirin in people with Japanese Encephalitis, run by Indian Council of Medical Research at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- Ribavirin
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2005to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child between 6 months and 12 years age
- Acute febrile encephalopathy
- Positive IgM ELISA test for Japanese encephalitis in serum
Who cannot join
- Consent not obtained
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
King George Medical University
Lucknow, Uttar Pradesh, 226003
Rashmi Kumar, MD, 91-522-2257377, rashmik2005@gmail.com
Rashmi Kumar, MD
About this study
Official title: Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial
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
- Being tested
- Ribavirin
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2005
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Indian Council of Medical Research
- Sponsor type
- Other government
- Investigators
- Rashmi Kumar, Principal investigator, King George Medical University, Lucknow INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216268
- Sponsor's protocol ID
- 5/8/7/1/13/2001-ECD1
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 9 Feb 2006
- Results posted
- No
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. doi: 10.1086/596309.
PubMed 19143532
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00216268
- Acronym / sponsor ID
- 5/8/7/1/13/2001-ECD1
- Conditions
- Japanese Encephalitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Indian Council of Medical ResearchOther government
- Study start
- Jul 2005
- Study completion
- May 2008
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child between 6 months and 12 years age
- Acute febrile encephalopathy
- Positive IgM ELISA test for Japanese encephalitis in serum
Key exclusion criteria (1 listed)
- Consent not obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ribavirin | Drug | – |
Primary outcome
Mortality during hospital stay
5 secondary outcomes
Sequelae at 3 months
Duration of hospital stay
Days to return to oral feeds
Days to become convulsion free
Days to become afebrile
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2006.
- Derived from this study: PubMed 19143532Kumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashmi Kumar principal investigator
King George Medical University, Lucknow INDIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ribavirin in people with Japanese Encephalitis, run by Indian Council of Medical Research at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rashmi Kumar, MD (91-522-2374777, rashmik2005@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality during hospital stay. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00216268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2006.