Respiratory Viral Infection in Nursing Home Slovenia

November 28, 2012 updated by: Nina Gorisek Miksic, University Maribor

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

Completed

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Maribor, Slovenia, SI-2000
        • Nursing home Tezno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nursing home residents and employees of the nursing home

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum vitamine D concentration in participants
Time Frame: 6 months
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
6 months
Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents
Time Frame: 6 months
Daily number of visitors in each nursing home room will be counted and correlate with the number of respiratory tract infection in participants.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nina Gorisek Miksic, MD, M.sc, University Medical Centre Maribor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

December 1, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (Estimate)

December 6, 2011

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 28, 2012

Last Verified

November 1, 2012

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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