Clinical trial NCT06318936: Respiratory Syncytial Virus (RSV) Burden in Older Adults in Primary Care in The Netherlands
Official title: RSV Burden in Older Adults in Primary Care in The Netherlands: the RAPID Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: RSV Infection
Keywords: older adults
RSV
burden
outpatient
primary care
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag B.V.
First posted: 2024-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All older adults (≥60 years of age) who visit their general practitioner because of acute respiratory tract symptoms such as shortness of breath, cough, sore throat or coryza (WHO definition) in one of the participating primary care practices in the Netherlands.

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.

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)

Primary outcomes:
measure: Burden of medically attended RSV infection in the Dutch primary care
timeFrame: Data will be collected at three timepoints (Day 0, Day 14 and Day 30 days after viral swab)
Secondary outcomes:
measure: RSV-related health care consumption and indirect costs in older adults
timeFrame: Data will be collected at three timepoints (Day 0, Day 14 and Day 30 days after viral swab)
measure: Proportion of medically attended RSV infection amongst all medically attended acute respiratory infections in older adults in the primary care setting
timeFrame: At day of sampling (Day 0)
measure: 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)
timeFrame: Data will be collected at three timepoints (Day 0, Day 14 and Day 30 after viral swab)
measure: Incidence of RSV-related secondary bacterial pneumonia events and antibiotic use
timeFrame: Data will be collected at the last timepoint (30 days after viral swab)
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Louis Bont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: