Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT01253967
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2010-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-09', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-12-02', 'lastUpdatePostDateStruct': {'date': '2015-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age', 'timeFrame': 'At least 12 months from study start'}], 'secondaryOutcomes': [{'measure': 'Age distribution of children with rotavirus gastroenteritis', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Potential risk factors for rotavirus gastroenteritis', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Rotavirus gastroenteritis associated costs', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Severity of rotavirus among all children < 5 years of age', 'timeFrame': 'At least 12 months from study'}, {'measure': 'Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age', 'timeFrame': 'At least 12 months from study start'}, {'measure': 'Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age', 'timeFrame': 'At least 12 months from study start'}]}, 'conditionsModule': {'keywords': ['Gastroenteritis', 'Hospital surveillance', 'Rotavirus gastroenteritis'], 'conditions': ['Infections, Rotavirus']}, 'referencesModule': {'references': [{'pmid': '25276665', 'type': 'DERIVED', 'citation': 'Benea OE, Streinu-Cercel A, Dorobat C, Rugina S, Negrutiu L, Cupsa A, Duiculescu D, Chiriac C, Itu C, Prisacariu LJ, Iosif I. Efficacy and safety of darunavir (Prezista((R))) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study. Germs. 2014 Sep 1;4(3):59-69. doi: 10.11599/germs.2014.1057. eCollection 2014 Sep.'}, {'pmid': '24967217', 'type': 'DERIVED', 'citation': 'Anca IA, Furtunescu FL, Plesca D, Streinu-Cercel A, Rugina S, Holl K. Hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children below five years of age in Romania. Germs. 2014 Jun 2;4(2):30-40. doi: 10.11599/germs.2014.1053. eCollection 2014 Jun.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children \\< 5 years of age in Romania.', 'detailedDescription': 'The study consist of a main study and a health economics study\n\nMain study: The study will focus on three different groups of patients:\n\n* Subjects who are hospitalised for acute gastroenteritis.\n* Subjects who visit an emergency room for acute gastroenteritis.\n* Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.\n\nHealth economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children \\< 5 years of age treated at a hospital site (subjects hospitalised with community acquired acute gastroenteritis, subjects who visited the emergency room for acute gastroenteritis or subjects with medical care associated rotavirus infection).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female child aged \\< 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday.\n* A subject, who during the study period:\n\n * Is hospitalised for acute gastroenteritis Or\n * Visits an emergency room for acute gastroenteritis Or\n * Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation\n\nExclusion Criteria:\n\nNot applicable'}, 'identificationModule': {'nctId': 'NCT01253967', 'briefTitle': 'Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania', 'orgStudyIdInfo': {'id': '110436'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Subjects who are hospitalised for acute gastroenteritis', 'interventionNames': ['Procedure: Collection of stool samples', 'Other: Health economics questionnaire']}, {'label': 'Group B', 'description': 'Subjects who visit an emergency room for acute gastroenteritis', 'interventionNames': ['Procedure: Collection of stool samples', 'Other: Health economics questionnaire']}, {'label': 'Group C', 'description': 'Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.', 'interventionNames': ['Procedure: Collection of stool samples', 'Other: Health economics questionnaire']}], 'interventions': [{'name': 'Collection of stool samples', 'type': 'PROCEDURE', 'description': 'Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Health economics questionnaire', 'type': 'OTHER', 'description': 'For a subset of subjects, additional economic data will be gathered by completing a questionnaire', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '021105', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400348', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '900708', 'city': 'Constanța', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Sibiu', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Timișoara', 'country': 'Romania', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}