Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT00820261
Status:
COMPLETED
Last Update Posted:
2012-09-07
First Post:
2009-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-01-23', 'releaseDate': '2012-12-13'}, {'resetDate': '2014-08-07', 'releaseDate': '2014-07-16'}], 'estimatedResultsFirstSubmitDate': '2012-12-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005440', 'term': 'Fluid Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The positive samples will be evaluated by sodium dodecyl polyacrylamide gel electrophoresis (SDS-PAGE) to determine the electropherotypes and genotyped using reverse transcriptase polymerase chain reaction (RT-PCR) on VP7 and VP4 gene and sequencing. Also, these positive samples will be retained for quality assurance and quality control.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 630}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-06', 'studyFirstSubmitDate': '2009-01-09', 'studyFirstSubmitQcDate': '2009-01-09', 'lastUpdatePostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage prevalence of rotavirus positive cases', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Any novel rotavirus strain detected by sequencing', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Genotypes', 'Epidemiology', 'Diarrhea'], 'conditions': ['Rotavirus']}, 'descriptionModule': {'briefSummary': 'Rotavirus is the most common cause of severe infantile diarrhoea disease in infants and young children below five years worldwide. It is associated with high cases of morbidity and mortality and it is estimated that up to 600,000 deaths in young children occur annually in the less developed countries and approximately 150,000-200,000 deaths occur in Africa alone. In Kenya, most rotavirus surveillance work has been done in Nairobi (an urban setting). Other parts e.g eastern Kenya, limited data is available and hence the prevalence and burden of rotavirus disease is under-estimated. We therefore hypothesize that rotavirus prevalence is high in Meru,Maua (a rural setting)and hence we designed a study to evaluate this.\n\nThis is a prospective study to determine, the rotavirus disease burden and epidemiology in infants and children with severe diarrhoea hospitalized in three sentinel hospital in the eastern part of Kenya (Maua Methodist hospital) will be carried out during the period January 2009 to December 2010.\n\nFaecal samples will be collected from infants and children admitted with acute diarrhoea and screened first for the presence of human serotype A rotavirus antigen using commercially available enzyme linked immunosorbent assay kit (ELISA).\n\nThe positive samples will be evaluated by sodium dodecyl polyacrylamide gel electrophoresis (SDS-PAGE) to determine the electropherotypes and genotyped using reverse transcriptase polymerase chain reaction (RT-PCR) on VP7 and VP4 gene.\n\nThese data/ results generated from this project will add crucial information on the rotavirus strains circulating in the eastern part of Kenya.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stool specimens will be collected from infants and young children below 5 years of age with severe diarrhea hospitalized in two government hospital (Maua Methodist hospital, during a two (2) year period', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Only children under 5 years of age who present with acute diarrhea having experienced an episode of 3 looser than normal or watery stools in a 24-hour period with or without episodes of vomiting will be enrolled in this study.\n* And the diarrhea should last for ≤ 7 days.\n* Clinical studies have indicated that the incubation period for rotavirus illness is less than 48hrs and usually will last for 5-7days (Steele, 1998) Based on this fact, and as per the WHO's Generic Protocol for Hospital based Surveillance of Rotavirus Gastroenteritis in children under 5 years of age (WHO Generic protocol, 2002)\n\nExclusion Criteria:\n\n* Children more than 5 years of age and with diarrhea lasting \\> 7 seven days and having bloody diarrhea will be excluded in the study.\n* This is as per the who's generic protocol for hospital based surveillance of rotavirus gastroenteritis in children under 5 years of age (WHO Generic Protocol, 2002)"}, 'identificationModule': {'nctId': 'NCT00820261', 'acronym': 'Rotavirus', 'briefTitle': 'Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Primate Research'}, 'officialTitle': 'Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya', 'orgStudyIdInfo': {'id': 'IISP35341'}, 'secondaryIdInfos': [{'id': 'IISP35341'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diarrhea', 'description': 'children and infants (less than 5 years of age) presenting with severe diarrhea will be enrolled', 'interventionNames': ['Other: oral rehydration therapy for diarrhea cases']}], 'interventions': [{'name': 'oral rehydration therapy for diarrhea cases', 'type': 'OTHER', 'description': 'Since rotavirus infection is a viral infection with no drug remedy, diarrhea cases will be managed according to the standard WHO protocol for the management of diarrhea. This will include oral rehydration treatment.', 'armGroupLabels': ['Diarrhea']}]}, 'contactsLocationsModule': {'locations': [{'zip': '254', 'city': 'Maua', 'state': 'Eastern', 'country': 'Kenya', 'facility': 'Maua Methodist Hospital', 'geoPoint': {'lat': 0.2332, 'lon': 37.94086}}], 'overallOfficials': [{'name': 'Atunga Nyachieo, PhD Biomedical Sciences', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Primate Research, Kenya'}, {'name': 'Nicholas M Kiulia, BSc Med Micro', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Primate Research, Kenya'}, {'name': 'Maureen B Taylor, DSc Virology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Virology Department, Univesity of Pretoria, South Africa'}, {'name': 'Walda van Zyl, PhD Virology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Virology Department, Univesity of Pretoria, South Africa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Primate Research', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Research Scientist', 'investigatorFullName': 'Atunga Nyachieo', 'investigatorAffiliation': 'Institute of Primate Research'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-12-13', 'type': 'RELEASE'}, {'date': '2013-01-23', 'type': 'RESET'}, {'date': '2014-07-16', 'type': 'RELEASE'}, {'date': '2014-08-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Atunga Nyachieo, Senior Research Scientist, Institute of Primate Research'}}}}