Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
132 participants
OBSERVATIONAL
2011-12-31
2012-11-30
Brief Summary
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At 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.
The 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.
During 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.
Our study hypothesis is that lower respiratory tract infections in elderly can be caused by viruses other than influenza.
The investigators would like to know if hypovitaminosis D is a risk factor for respiratory tract infections in nursing home residents and employees.
The 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.
Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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nursing home residents
participants in this group are nursing home residents
No interventions assigned to this group
Nursing home employees
Participants in this group are health care workers, employees at the nursing home
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University of Ljubljana School of Medicine, Slovenia
OTHER
University Medical Centre Maribor
OTHER
University Medical Centre Ljubljana
OTHER
University Maribor
OTHER
Responsible Party
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Nina Gorisek Miksic
Nina Gorisek Miksic, MD, M.Sc, infectologist
Principal Investigators
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Nina Gorisek Miksic, MD, M.sc
Role: PRINCIPAL_INVESTIGATOR
University Medical Centre Maribor
Locations
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Nursing home Tezno
Maribor, Maribor City Municipality, Slovenia
Countries
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References
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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.
Mahony JB. Detection of respiratory viruses by molecular methods. Clin Microbiol Rev. 2008 Oct;21(4):716-47. doi: 10.1128/CMR.00037-07.
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.
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.
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.
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.
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.
Other Identifiers
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DSO-2011-2012
Identifier Type: -
Identifier Source: org_study_id