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

NCT ID: NCT06318936

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-05-01

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.

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.

Conditions

RSV Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Older adults with RSV infection

Adults aged ≥60 years attending primary care with acute respiratory tract infecion

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag B.V.

INDUSTRY

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Louis Bont

Prof. dr. Louis Bont

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis Bont, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Joanne G Wildenbeest, MD, PhD

Role: CONTACT

J.G.Wildenbeest@umcutrecht.nl

0031887563776

Sarah F Hak, MD

Role: CONTACT

s.f.hak@umcutrecht.nl

+31621416137

Facility Contacts

Joanne Wildenbeest, MD, PhD

Role: primary

J.G.Wildenbeest@umcutrecht.nl

0031887563776

Other Identifiers

22-677

Identifier Type: -

Identifier Source: org_study_id