Acute Viral Respiratory Tract Diseases Clinical Trial
Official title:
Etiology, Frequency and Epidemiology of Respiratory Viral Infection in Nursing Home Residents
| Verified date | November 2012 |
| Source | University Maribor |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Slovenia: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 132 |
| Est. completion date | November 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - resident of the nursing home or employee ni the nursing home Exclusion Criteria: |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Slovenia | Nursing home Tezno | Maribor |
| Lead Sponsor | Collaborator |
|---|---|
| University Maribor | University Clinical Centre, Maribor, University Medical Centre Ljubljana, University of Ljubljana School of Medicine, Slovenia |
Slovenia,
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. — View 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/archint — View Citation
Jartti L, Langen H, Söderlund-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. — View Citation
Laaksi I, Ruohola JP, Mattila V, Auvinen A, Ylikomi T, Pihlajamäki 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. do — View 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. Review. — View 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:S284-9. doi: 10.1093/cid/cir043. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Serum vitamine D concentration in participants | 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 | No |
| Secondary | Daily number of visitors in nursing home in correlation with the number of respiratory tract infection in residents | 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 | No |