Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-29 @ 12:02 AM
Study NCT ID:
NCT00216268
Status:
UNKNOWN
Last Update Posted:
2006-02-09
First Post:
2005-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Japanese Encephalitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004672', 'term': 'Encephalitis, Japanese'}], 'ancestors': [{'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2008-05'}, 'lastUpdateSubmitDate': '2006-02-08', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2006-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality during hospital stay'}], 'secondaryOutcomes': [{'measure': 'Sequelae at 3 months'}, {'measure': 'Duration of hospital stay'}, {'measure': 'Days to return to oral feeds'}, {'measure': 'Days to become convulsion free'}, {'measure': 'Days to become afebrile'}]}, 'conditionsModule': {'conditions': ['Japanese Encephalitis']}, 'referencesModule': {'references': [{'pmid': '19143532', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child between 6 months and 12 years age\n* Acute febrile encephalopathy\n* Positive IgM ELISA test for Japanese encephalitis in serum\n\nExclusion Criteria:\n\n* Consent not obtained'}, 'identificationModule': {'nctId': 'NCT00216268', 'briefTitle': 'Treatment of Japanese Encephalitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Indian Council of Medical Research'}, 'officialTitle': 'Treatment of Japanese Encephalitis - a Double Blind Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '5/8/7/1/13/2001-ECD1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ribavirin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '226003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Rashmi Kumar, MD', 'role': 'CONTACT', 'email': 'rashmik2005@gmail.com', 'phone': '91-522-2257377'}, {'name': 'Rashmi Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'King George Medical University', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}], 'centralContacts': [{'name': 'Rashmi Kumar, MD', 'role': 'CONTACT', 'email': 'rashmik2005@gmail.com', 'phone': '91-522-2374777'}], 'overallOfficials': [{'name': 'Rashmi Kumar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King George Medical University, Lucknow INDIA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indian Council of Medical Research', 'class': 'OTHER_GOV'}}}}