- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01486160
Respiratory Viral Infection in Nursing Home Slovenia
Etiology, Frequency and Epidemiology of Respiratory Viral Infection in Nursing Home Residents
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.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Maribor, Slovenia, SI-2000
- Nursing home Tezno
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- resident of the nursing home or employee ni the nursing home
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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nursing home residents
participants in this group are nursing home residents
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Nursing home employees
Participants in this group are health care workers, employees at the nursing home
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of viral respiratory tract infection in participants according to etiology
Time Frame: 6 months
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Number of participants with upper and lower respiratory tract infection will be detected and etiology of viral infection will be identified
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum vitamine D concentration in participants
Time Frame: 6 months
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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
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6 months
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Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents
Time Frame: 6 months
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Daily number of visitors in each nursing home room will be counted and correlate with the number of respiratory tract infection in participants.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nina Gorisek Miksic, MD, M.sc, University Medical Centre Maribor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSO-2011-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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