RSV-infection RS-virus infection
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Male and female adults *60 years of age - Willing and able to give written informed consent - Willing and able to adhere to protocol-specified procedures
Exclusion criteria
Exclusion criteria: - Current alcohol or drug abuse or history of unsuccessfully treated alcohol or drug abuse within the past year - Unable to perform the study procedures - Dementia - Life expectancy less than 1 year - Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination (a more detailed description/list can be found in appendix 3 of the study protocol). - Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to study participation. The use of topical, inhaled, and nasal glucocorticoids will be permitted (a more detailed description/list can be found in appendix 3 of the study protocol). - Previous participation in this study or in a RSV interventional trial (vaccine, antivirals) - Planned leave/holiday during the winter season of more than 1 month in total.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: * To estimate the incidence of RSV infection-associated ARTI, RSV MA-ARTI and RSV hospitalization in older adults. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: * To estimate the rate of all-cause MA (inpatient or outpatient) ARTI and related medical complications (exacerbations of chronic conditions, acute cardiovascular events). * To estimate the RSV-associated and all-cause mortality. * To estimate health care costs, health care resource use, interruption of normal activities, and Health Related Quality of Life (HRQoL) in RSV-associated and all-cause MA (inpatient or outpatient) ARTI patients. * To estimate the incidence of RSV-related secondary bacterial pneumonia events and their association with antibiotic use within 21 days after onset of RSV infection. * To collect clinical samples for biomarker analysis. * To examine the incidence of other respiratory pathogens associated with all MA-ARTI * To estimate the proportion of acute viral ARTI attributable to RSV. * To estimate important risk factors for RSV infections (by severity and healthcare utilizations). * To determine change in frailty over the course of the study. | — |
Countries
Belgium, Netherlands, United Kingdom