Respiratory Viral Infection in Nursing Home Slovenia

NCT01486160 | Completed

• 1 other identifier: DSO-2011-2012
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Viral Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

• Number of viral respiratory tract infection in participants according to etiology

  Number of participants with upper and lower respiratory tract infection will be detected and etiology of viral infection will be identified

  6 months

Secondary Outcomes (2)

• Serum vitamine D concentration in participants

  6 months

• Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents

  6 months

Study Arms (2)

nursing home residents

participants in this group are nursing home residents

Nursing home employees

Participants in this group are health care workers, employees at the nursing home

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Nursing home residents and employees of the nursing home

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University Maribor: lead
• University of Ljubljana School of Medicine, Slovenia: collaborator
• University Medical Centre Maribor: collaborator
• University Medical Centre Ljubljana: collaborator

Study Sites (1)

Nursing home Tezno

Maribor, Maribor City Municipality, SI-2000, Slovenia

Location

Related Publications (7)

• 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: 8259806 BACKGROUND

• 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: 18854489 RESULT

• 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: 21460286 RESULT

• 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: 21760867 RESULT

• 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: 20632889 RESULT

• 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: 19237723 RESULT

• 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.

  PMID: 27814689 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Officials

• Nina Gorisek Miksic, MD, M.sc

  University Medical Centre Maribor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nina Gorisek Miksic, MD, M.Sc, infectologist

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 6, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 30, 2012

Record last verified: 2012-11

Locations

SL (1)