To determine the burden of disease due to RSV in older adults.
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
* To estimate the incidence of RSV infection-associated ARTI, RSV MA-ARTI and
RSV hospitalization in older adults.
Secondary outcome
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.
Background summary
The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative
Medicine Initiative (IMI) funded by the EU and EFPIA under the H2020 framework
to define and understand the burden of disease caused by human respiratory
syncytial virus (RSV) infection.
RSV causes severe disease in individuals at the extremes of the age spectrum
and in high risk groups such as patients with COPD. Published data on the
burden of disease of RSV in the elderly population is mainly from research
groups in the United States and focuses mainly on hospitalized patients. The
estimated burden of disease in older adults is comparable with non-pandemic
influenza. These estimates were based on limited data and there is a
substantial gap in knowledge on morbidity and associated healthcare and social
costs in Europe. New vaccines and therapeutics against RSV are in development
and could soon be available on the European market.
RESCEU will deliver knowledge of the incidence and burden of RSV disease in
young children and older adults in Europe, which is essential for stakeholders
(governments, etc.) to take decisions about prophylaxis and treatment.
Study objective
To determine the burden of disease due to RSV in older adults.
Study design
This will be a multi-country, multicenter, prospective, observational cohort
study.
In the Netherlands the study will be monocenter (UMCU) with the collaboration
of general practitioners offices who function as recruitment centers.
Study burden and risks
The burden of study participation will consist of the following:
Sample collection:
For all participants:
- Venepuncture: 2× 60ml (start and end of the RSV season)
- Nasopharyngeal swab: 2× (start and end of the RSV season)
Only for participants with an acute respiratory tract infection:
- Nasopharyngeal swab: 2× at each new episode of a respiratory infection
(POCT/PCR)
- Oropharyngeal swab: 1× at each new episode of a respiratory infection
Only for participants with a RSV ALRI:
- Venepuncture: 1× 60ml at the moment of acute infection, 1× 30ml 1-2 weeks
after the start of acute RSV infection
- Nasopharyngeal swab: 1× at the moment of acute infection, 1× 1-2 weeks after
the start of acute RSV infection
Questionnaires:
For all participants:
- Baseline questionnaire
- Quality of life baseline meassurement (2× at inclusion and after 1 year)
- 1-year questionnaire
- During the RSV season (October up till May); weekly questionnaire with one
question: are there respiratory symptoms?
Only in participants who experience respiratory symptoms during the RSV season:
- Diary on respiratory symptoms (daily until the end of the infection)
- Quality of life questionnaire (daily until the end of the infection)
- End of infection questionnaire when the symptoms are gone.
Although there is a risk of minor complications such as bruising following a
blood draw or epistaxis after a nasopharyngeal swab, there is no risk of severe
complications. Therefore we believe that the burden of participation is
acceptable in the light of the gained knowledge that will result from this
research. Information from this study can inform us about the burden of disease
in this population and may help us treat or prevent severe RSV infections in
the future.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60910.041.17 |