Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT01706302
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2012-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom From 1995 to 2009
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-25', 'studyFirstSubmitDate': '2012-10-11', 'studyFirstSubmitQcDate': '2012-10-11', 'lastUpdatePostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes.', 'timeFrame': 'From 1995 to 2009'}], 'secondaryOutcomes': [{'measure': 'Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with non-respiratory outcomes.', 'timeFrame': 'From 1995 to 2009'}, {'measure': 'Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP prescription of antibiotics relevant to respiratory disease, by age and risk group.', 'timeFrame': 'From 1995 to 2009'}, {'measure': 'Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.', 'timeFrame': 'From 1995 to 2009'}, {'measure': 'Occurrence of potentially RSV-attributable deaths among the total number of RSV-attributable hospitalizations and cases, by age and risk group.', 'timeFrame': 'From 1995 to 2009'}]}, 'conditionsModule': {'keywords': ['General Practice Research Database', 'Burden of Disease', 'Clinical Practice Research Datalink', 'Hospital Episode Statistics', 'Office of National Statistics', 'RSV'], 'conditions': ['Respiratory Syncyctial Virus Vaccines']}, 'referencesModule': {'references': [{'pmid': '27256085', 'type': 'DERIVED', 'citation': 'Taylor S, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Fleming DM. Modelling estimates of the burden of respiratory syncytial virus infection in children in the UK. BMJ Open. 2016 Jun 2;6(6):e009337. doi: 10.1136/bmjopen-2015-009337.'}, {'pmid': '26497750', 'type': 'DERIVED', 'citation': 'Fleming DM, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Taylor S. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis. 2015 Oct 23;15:443. doi: 10.1186/s12879-015-1218-z.'}]}, 'descriptionModule': {'briefSummary': 'The study will assess the burden of RSV-attributable general practice consultations, hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.', 'detailedDescription': 'This epidemiological study is based on an already existing database of time series regression modeling outputs generated during the generated by EPI-FLU-018 BOD UK DB (116273) study, which estimated the burden of influenza in terms of General Practitioner (GP) consultations, hospitalizations, and deaths associated with various respiratory and non-respiratory outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects included in the 116273 study who were registered with an acceptable flag in the CPRD, or with a potentially RSV-related event in the HES database or the ONS mortality data.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Included in the EPI-FLU-018 BOD UK DB BOD UK DB (eTrack: 116273) study database. The inclusion criterion for EPI-FLU-018 was registration with an acceptable flag in the CPRD, or registration in the HES database or the ONS mortality data with a flu-related event.\n\nExclusion Criteria:\n\n• Not Applicable'}, 'identificationModule': {'nctId': 'NCT01706302', 'briefTitle': 'Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom From 1995 to 2009', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom, 1995 to 2009', 'orgStudyIdInfo': {'id': '116357'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort Group', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'The previous study has used four primary data sources: the General Practice Research Data (GPRD \\[recently re-named Clinical Practice Research Datalink (CPRD)\\], for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA). The extracted data are referred to as the EPI-FLU-018 BOD UK DB database. Weekly time series will be generated to estimate the RSV burden and characterize it in terms of incidence of GP consultations, hospitalizations and deaths for each of the respiratory and non-respiratory outcomes (including GP antibiotic prescriptions), stratified by age and risk group.', 'armGroupLabels': ['Cohort Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sage Analytica', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}