Respiratory Syncytial Virus (RSV) Burden in Older Adults in Primary Care in The Netherlands

RSV Infection Clinical Trial

— RAPID  

Official title:

RSV Burden in Older Adults in Primary Care in The Netherlands: the RAPID Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318936
• Other study ID #: 22-677
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: UMC Utrecht
• Contact: Joanne G Wildenbeest, MD, PhD
• Phone: 0031887563776
• Email: J.G.Wildenbeest[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age (=60 years of age)
• RSV positive
• Subject is willing and able to give informed consent for participation in the study
• Subject is willing and able to adhere to protocol-specific procedures

Exclusion Criteria:

• Subject is not able to understand and communicate in the local language or English.
• Previous or current participation in RSV interventional trial (vaccine, antivirals)

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• RSV Infection

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Janssen-Cilag B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burden of medically attended RSV infection in the Dutch primary care	The burden of medically attended RSV infection in the Dutch primary care setting will be defined as severity and duration of clinical symptoms, and healthcare resource use.	Data will be collected at three timepoints (Day 0, Day 14 and Day 30 days after viral swab)
Secondary	RSV-related health care consumption and indirect costs in older adults	Health care utilization will be calculated as the number of contact moments (including phone contacts, telemedicine and visits) with the GP-practices and other health-care providers (e.g. visit to specialist, emergency department). For hospitalized adults, the number of admitted days and the level of care (general ward, high dependency unit, intensive care unit) will be calculated.; Medical costs and socio-economic costs will be calculated based on the questionnaires at day 0, 14 and day 30.	Data will be collected at three timepoints (Day 0, Day 14 and Day 30 days after viral swab)
Secondary	Proportion of medically attended RSV infection amongst all medically attended acute respiratory infections in older adults in the primary care setting	The proportion of RSV positive older adults will be calculated as the number of older adults who tested positive for RSV divided by the total number of older adults who visit the participating GP practices because of ARTIs and were tested for RSV.	At day of sampling (Day 0)
Secondary	Association between disease severity and several clinical and demographic parameters (e.g. age, cardiopulmonary comorbidity, smoking status, chronic immunosuppressive medication use) and RSV burden (by disease severity and healthcare usage)	We will explore potential risk factors ((e.g. age, cardiopulmonary comorbidity, smoking status, polypharmacy, chronic immunosuppressive medication use) for severe RSV disease.	Data will be collected at three timepoints (Day 0, Day 14 and Day 30 after viral swab)
Secondary	Incidence of RSV-related secondary bacterial pneumonia events and antibiotic use	Incidence will be calculated as the proportion of subjects that show RSV-associated secondary bacterial pneumonia events (defined as pneumonia within 21 days after RSV infection) and antibiotic use.	Data will be collected at the last timepoint (30 days after viral swab)