Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318936
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-01-21
Brief Title:
Respiratory Syncytial Virus RSV Burden in Older Adults in Primary Care in The Netherlands
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
RSV Burden in Older Adults in Primary Care in The Netherlands the RAPID Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPID
Brief Summary:
RSV infection is a leading cause of medical care in older adults sometimes leading to hospital admission and severe outcomes Although the majority of RSV infections are managed outside hospitals little is known on the burden of RSV in older adults in the primary care setting Accurate estimates of the RSV burden in primary care is particularly relevant since vaccines against RSV infection in older adults will likely become available for the general population soon The use of high-quality point-of-care POC molecular viral diagnostics allows to identify RSV infected older adults and would therefore contribute to fill one of the most important gaps in knowledge facilitating implementation of RSV vaccination of older adults
With this prospective observational study we aim to define the disease burden of RSV infection in older adults in the primary care setting
With this prospective observational study we aim to define the disease burden of RSV infection in older adults in the primary care setting
Detailed Description:
Th RAPID study is a prospective observational study in Dutch primary care practices during two RSV seasons As part of routine care rapid molecular viral diagnostic testing on respiratory samples will be offered to all older adults attending the primary care physician because of symptoms of acute respiratory tract infection ARTI RSV positive cases will be included for further study Participants will be asked to fill out three questionnaires by phone or by online at day 0 14 and 30 after the GP-visit
The main endpoint is the burden of medically attended RSV infection in the Dutch primary care setting quantified using several clinical and socioeconomic parameters including but not limited to clinical symptoms and their duration medicine use hospitalisation rate quality of life and ability to perform normal daily activities Secondary data on health care consumption and indirect costs will be collected and we will assess the effect of age and severe comorbidity on clinical course of RSV disease
A population size of 1000 older adults age 60 years presenting with acute respiratory symptoms to the general practitioner GP during RSV season will be tested for RSV as part of routine care We expect about 100 RSV Based on our sample size calculation 100 RSV cases would provide sufficient accuracy for estimating the relevant outcomes
The main endpoint is the burden of medically attended RSV infection in the Dutch primary care setting quantified using several clinical and socioeconomic parameters including but not limited to clinical symptoms and their duration medicine use hospitalisation rate quality of life and ability to perform normal daily activities Secondary data on health care consumption and indirect costs will be collected and we will assess the effect of age and severe comorbidity on clinical course of RSV disease
A population size of 1000 older adults age 60 years presenting with acute respiratory symptoms to the general practitioner GP during RSV season will be tested for RSV as part of routine care We expect about 100 RSV Based on our sample size calculation 100 RSV cases would provide sufficient accuracy for estimating the relevant outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None