Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-01-01 @ 9:14 PM
Study NCT ID:
NCT00895492
Status:
COMPLETED
Last Update Posted:
2014-05-01
First Post:
2009-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 967}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2009-05-06', 'studyFirstSubmitQcDate': '2009-05-07', 'lastUpdatePostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of rotavirus VP7 and VP4 genotypes', 'timeFrame': 'two years'}], 'secondaryOutcomes': [{'measure': 'Proportion of rotavirus positive episodes', 'timeFrame': 'two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diarrhea', 'rotavirus', 'genotype', 'VP4', 'VP7'], 'conditions': ['Acute Diarrheal Disease', 'Rotavirus Infection']}, 'referencesModule': {'references': [{'pmid': '17195704', 'type': 'BACKGROUND', 'citation': "O'Ryan M, Diaz J, Mamani N, Navarrete M, Vallebuono C. Impact of rotavirus infections on outpatient clinic visits in chile. Pediatr Infect Dis J. 2007 Jan;26(1):41-5. doi: 10.1097/01.inf.0000247104.01291.71."}, {'pmid': '11465841', 'type': 'BACKGROUND', 'citation': "O'Ryan M, Perez-Schael I, Mamani N, Pena A, Salinas B, Gonzalez G, Gonzalez F, Matson DO, Gomez J. Rotavirus-associated medical visits and hospitalizations in South America: a prospective study at three large sentinel hospitals. Pediatr Infect Dis J. 2001 Jul;20(7):685-93. doi: 10.1097/00006454-200107000-00009."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization) in a large public hospital from Valparaiso and another from Santiago.', 'detailedDescription': "Rotavirus is the leading cause of gastroenteritis in children. Our group has developed a surveillance system for acute rotavirus diarrhea in two large hospitals in Chile since 2006. Patients visiting the ER for acute non-bloody diarrhea will be enrolled after an informed consent is signed by parents. A fresh stool sample will be collected to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization. Stool samples will be tested for rotavirus by ELISA IDEIA - Rotavirus - OXOID. Rotavirus positive samples will be genotyped as described previously (Iturriza-Gomara et al. J. Clinical Virol 2004). Overall medical visits and hospitalizations, proportion of visits and hospitalizations caused by acute diarrhea, estimated numbers of rotavirus visits and hospitalizations will be calculated for each site. Proportion of rotavirus VP7 and VP4 genotypes will be calculated for three month periods per center. Differences in proportion will be compared by chi square and Fischer's exact test when appropriate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children younger than 5 years of age with acute diarrhea or related diagnosis requiring emergency room and hospital admission in two large cities in Chile', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with acute diarrhea\n* Children younger than 5 years\n\nExclusion Criteria:\n\n* Illiterate parents\n* Chronic gastrointestinal disease'}, 'identificationModule': {'nctId': 'NCT00895492', 'briefTitle': 'Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Two Year (2009-2010) Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years of Age Requiring Emergency Room and Hospital Admission in Two Large Cities in Chile.', 'orgStudyIdInfo': {'id': 'Merck 2009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sotero del Rio', 'description': 'Emergency Room and Hospital based surveillance'}, {'label': 'Van Buren', 'description': 'Emergency Room and Hospital based surveillance'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Valparaíso', 'state': 'Región de Valparaíso', 'country': 'Chile', 'facility': 'Hospital Van Buren', 'geoPoint': {'lat': -33.036, 'lon': -71.62963}}, {'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Hospital Dr Sotero del Rio', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': "Miguel L O'Ryan, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Microbiology and Micology Program, Faculty of Medicine, University of Chile'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor, Microbiology and Mycology Department of Medicine Faculty, Universidad de Chile.', 'investigatorFullName': "Miguel O'Ryan Gallardo", 'investigatorAffiliation': 'University of Chile'}}}}