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REspiratory Syncytial virus Consortium in EUrope (RESCEU) study: Defining the burden of disease of Respiratory Syncytial Virus in older adults in Europe.

REspiratory Syncytial virus Consortium in EUrope (RESCEU) study: Defining the burden of disease of Respiratory Syncytial Virus in older adults in Europe. - Burden of disease of RSV in older adults

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45431
Enrollment
333
Registered
2017-07-18
Start date
2017-09-04
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RSV-infection RS-virus infection

Interventions

Burden of disease
Older adults
Respiratory infection
RSV (Respiratory Syncytial Virus)

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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

MeasureTime frame
Primary Objective: * To estimate the incidence of RSV infection-associated ARTI, RSV MA-ARTI and RSV hospitalization in older adults.

Secondary

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)