Clinical trial NCT01486160: Respiratory Viral Infection in Nursing Home Slovenia
Official title: Etiology, Frequency and Epidemiology of Respiratory Viral Infection in Nursing Home Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Viral Respiratory Tract Diseases
Lead sponsor: University Maribor
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
name: University Medical Centre Maribor
name: University Medical Centre Ljubljana
First posted: 2011-12-06
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing home residents and employees of the nursing home

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* resident of the nursing home or employee ni the nursing home

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of viral respiratory tract infection in participants according to etiology
timeFrame: 6 months
Secondary outcomes:
measure: Serum vitamine D concentration in participants
timeFrame: 6 months
measure: Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents
timeFrame: 6 months
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: Nursing home Tezno
Study officials:
affiliation: University Medical Centre Maribor
name: Nina Gorisek Miksic, MD, M.sc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.