Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT01486160
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2011-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Viral Infection in Nursing Home Slovenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-28', 'studyFirstSubmitDate': '2011-12-01', 'studyFirstSubmitQcDate': '2011-12-05', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of viral respiratory tract infection in participants according to etiology', 'timeFrame': '6 months', 'description': 'Number of participants with upper and lower respiratory tract infection will be detected and etiology of viral infection will be identified'}], 'secondaryOutcomes': [{'measure': 'Serum vitamine D concentration in participants', 'timeFrame': '6 months', 'description': 'Serum concentration of vitamine D will be measured retrospectively from the blood samples taken at the beginning of the study and correlation between vitamine D concentration and the frequency of respiratory tract infection in participants will be made'}, {'measure': 'Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents', 'timeFrame': '6 months', 'description': 'Daily number of visitors in each nursing home room will be counted and correlate with the number of respiratory tract infection in participants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Viral Respiratory Tract Diseases']}, 'referencesModule': {'references': [{'pmid': '8259806', 'type': 'BACKGROUND', 'citation': 'Beck-Sague C, Banerjee S, Jarvis WR. Infectious diseases and mortality among US nursing home residents. Am J Public Health. 1993 Dec;83(12):1739-42. doi: 10.2105/ajph.83.12.1739.'}, {'pmid': '18854489', 'type': 'RESULT', 'citation': 'Mahony JB. Detection of respiratory viruses by molecular methods. Clin Microbiol Rev. 2008 Oct;21(4):716-47. doi: 10.1128/CMR.00037-07.'}, {'pmid': '21460286', 'type': 'RESULT', 'citation': 'Pavia AT. Viral infections of the lower respiratory tract: old viruses, new viruses, and the role of diagnosis. Clin Infect Dis. 2011 May;52 Suppl 4(Suppl 4):S284-9. doi: 10.1093/cid/cir043.'}, {'pmid': '21760867', 'type': 'RESULT', 'citation': 'Jartti L, Langen H, Soderlund-Venermo M, Vuorinen T, Ruuskanen O, Jartti T. New respiratory viruses and the elderly. Open Respir Med J. 2011;5:61-9. doi: 10.2174/1874306401105010061. Epub 2011 Jul 6.'}, {'pmid': '20632889', 'type': 'RESULT', 'citation': 'Laaksi I, Ruohola JP, Mattila V, Auvinen A, Ylikomi T, Pihlajamaki H. Vitamin D supplementation for the prevention of acute respiratory tract infection: a randomized, double-blinded trial among young Finnish men. J Infect Dis. 2010 Sep 1;202(5):809-14. doi: 10.1086/654881. No abstract available.'}, {'pmid': '19237723', 'type': 'RESULT', 'citation': 'Ginde AA, Mansbach JM, Camargo CA Jr. Association between serum 25-hydroxyvitamin D level and upper respiratory tract infection in the Third National Health and Nutrition Examination Survey. Arch Intern Med. 2009 Feb 23;169(4):384-90. doi: 10.1001/archinternmed.2008.560.'}, {'pmid': '27814689', 'type': 'DERIVED', 'citation': 'Ursic T, Miksic NG, Lusa L, Strle F, Petrovec M. Viral respiratory infections in a nursing home: a six-month prospective study. BMC Infect Dis. 2016 Nov 4;16(1):637. doi: 10.1186/s12879-016-1962-8.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted in a 208-bed nursing home in Maribor. The investigators will observe a group of a 100 nursing-home residents and 50 health care workers- employees in the nursing home- in a six months period.Influenza vaccination status will be recorded in all participants at the beginning.\n\nAt the beginning and at the end of the study the blood samples for vitamin D concentration determination and nasopharyngeal swabs for molecular detection of respiratory viruses will taken in all of the participants.\n\nThe study will observe number of viral respiratory tract infection in participants and identify the viral etiology of infections during 6 months observational period.Nasopharyngeal swab and blood sample will be taken in each of the participant who will suffer an acute respiratory tract infection (upper or lower respiratory tract infection) and viral agents of respiratory tract diseases will be searched for. The investigators will try to detect different viral agents of respiratory tract infection: human rhinoviruses, enteroviruses, influenza A, B, parainfluenza 1-4, respiratory syncytial virus, human coronaviruses, human metapneumovirus, adenoviruses and human bocavirus with newer molecular methods (real-time polymerase chain reaction, real-time reverse transcriptase polymerase chain reaction) in nasopharyngeal swab and in blood sample of the participants.\n\nDuring the study period the investigators will monitor the daily number of visitors (adults, preschool children and pupils) in each nursing home room. The epidemiological aspect of respiratory viral infection will be assessed.\n\nOur study hypothesis is that lower respiratory tract infections in elderly can be caused by viruses other than influenza.\n\nThe investigators would like to know if hypovitaminosis D is a risk factor for respiratory tract infections in nursing home residents and employees.\n\nThe investigators would also like to know if the number of respiratory tract infections in elderly correlates with the number of visitors in nursing home, small children in particular.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nursing home residents and employees of the nursing home', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* resident of the nursing home or employee ni the nursing home\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01486160', 'briefTitle': 'Respiratory Viral Infection in Nursing Home Slovenia', 'organization': {'class': 'OTHER', 'fullName': 'University Maribor'}, 'officialTitle': 'Etiology, Frequency and Epidemiology of Respiratory Viral Infection in Nursing Home Residents', 'orgStudyIdInfo': {'id': 'DSO-2011-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'nursing home residents', 'description': 'participants in this group are nursing home residents'}, {'label': 'Nursing home employees', 'description': 'Participants in this group are health care workers, employees at the nursing home'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SI-2000', 'city': 'Maribor', 'state': 'Maribor City Municipality', 'country': 'Slovenia', 'facility': 'Nursing home Tezno', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}], 'overallOfficials': [{'name': 'Nina Gorisek Miksic, MD, M.sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Maribor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Maribor', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ljubljana School of Medicine, Slovenia', 'class': 'OTHER'}, {'name': 'University Medical Centre Maribor', 'class': 'OTHER'}, {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nina Gorisek Miksic, MD, M.Sc, infectologist', 'investigatorFullName': 'Nina Gorisek Miksic', 'investigatorAffiliation': 'University Maribor'}}}}