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Respiratory Viral Infection in Nursing Home Slovenia

This study has been completed.
Sponsor:
Collaborators:
University of Ljubljana School of Medicine, Slovenia
University Clinical Centre, Maribor
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Nina Gorisek Miksic, University Maribor
ClinicalTrials.gov Identifier:
NCT01486160
First received: December 1, 2011
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Acute Viral Respiratory Tract Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Etiology, Frequency and Epidemiology of Respiratory Viral Infection in Nursing Home Residents

Resource links provided by NLM:

MedlinePlus related topics: Nursing Homes
U.S. FDA Resources

Further study details as provided by University Maribor:

Primary Outcome Measures:
  • Number of viral respiratory tract infection in participants according to etiology [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of participants with upper and lower respiratory tract infection will be detected and etiology of viral infection will be identified


Secondary Outcome Measures:
  • Serum vitamine D concentration in participants [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Daily number of visitors in each nursing home room will be counted and correlate with the number of respiratory tract infection in participants.


Biospecimen Retention:   Samples With DNA

whole blood


Enrollment: 132
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Nursing home residents and employees of the nursing home

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486160

Locations
Slovenia
Nursing home Tezno
Maribor, Slovenia, SI-2000
Sponsors and Collaborators
University Maribor
University of Ljubljana School of Medicine, Slovenia
University Clinical Centre, Maribor
University Medical Centre Ljubljana
Investigators
Principal Investigator: Nina Gorisek Miksic, MD, M.sc University Clinical Centre, Maribor
  More Information

Publications:

Responsible Party: Nina Gorisek Miksic, Nina Gorisek Miksic, MD, M.Sc, infectologist, University Maribor
ClinicalTrials.gov Identifier: NCT01486160     History of Changes
Other Study ID Numbers: DSO-2011-2012
Study First Received: December 1, 2011
Last Updated: November 28, 2012
Health Authority: Slovenia: Ethics Committee

Additional relevant MeSH terms:
Respiratory Tract Diseases
Virus Diseases

ClinicalTrials.gov processed this record on June 18, 2013