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

NCT06318936 | Recruiting

• 1 other identifier: 22-677
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

RSV Infection

Keywords

older adults; RSV; burden; outpatient; primary care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• RSV-related health care consumption and indirect costs in older adults

  Data will be collected at three timepoints (Day 0, Day 14 and Day 30 days after viral swab)

• Proportion of medically attended RSV infection amongst all medically attended acute respiratory infections in older adults in the primary care setting

  At day of sampling (Day 0)

• 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)

  Data will be collected at three timepoints (Day 0, Day 14 and Day 30 after viral swab)

• Incidence of RSV-related secondary bacterial pneumonia events and antibiotic use

  Data will be collected at the last timepoint (30 days after viral swab)

Study Arms (1)

Older adults with RSV infection

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead
• Janssen-Cilag B.V.: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal swab

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Louis Bont, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne G Wildenbeest, MD, PhD

CONTACT

0031887563776; J.G.Wildenbeest@umcutrecht.nl

Sarah F Hak, MD

CONTACT

+31621416137; s.f.hak@umcutrecht.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Louis Bont

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: March 19, 2024
• Study Start: November 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

NL (1)