RSV InfectionRAPIDNCT06318936
Respiratory Syncytial Virus (RSV) Burden in Older Adults in Primary Care in The Netherlands
An observational study of RSV Infection, run by UMC Utrecht at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- RSV Infection
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2022to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Subject is not able to understand and communicate in the local language or English.
- Previous or current participation in RSV interventional trial (vaccine, antivirals)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3584CX
Joanne Wildenbeest, MD, PhD, 0031887563776, J.G.Wildenbeest@umcutrecht.nl
About this study
Official title: RSV Burden in Older Adults in Primary Care in The Netherlands: the RAPID Study
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.
Read the 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
- Keywords
- older adults, RSV, burden, outpatient, primary care
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older adults with RSV infection | Adults aged ≥60 years attending primary care with acute respiratory tract infecion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
We will explore potential risk factors ((e.g. age, cardiopulmonary comorbidity, smoking status, polypharmacy, chronic immunosuppressive medication use) for severe RSV disease.
Measured: 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
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.
Measured: Data will be collected at the last timepoint (30 days after viral swab)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Nov 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag B.V.
- Responsible party
- Principal investigator, Louis Bont, UMC Utrecht
- Investigators
- Louis Bont, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318936
- Sponsor's protocol ID
- 22-677
- Acronym
- RAPID
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RSV Burden in Older Adults in Primary Care in The Netherlands: the RAPID Study
- ClinicalTrials.gov ID
- NCT06318936
- Acronym / sponsor ID
- RAPID / 22-677
- Conditions
- RSV Infection
- Keywords
- older adults, RSV, burden, outpatient, primary care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Janssen-Cilag B.V.
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults with RSV infection | – | –Adults aged ≥60 years attending primary care with acute respiratory tract infecion |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Subject is not able to understand and communicate in the local language or English.
- Previous or current participation in RSV interventional trial (vaccine, antivirals)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Burden of medically attended RSV infection in the Dutch primary care
Time frame: Data will be collected at three timepoints (Day 0, Day 14 and Day 30 days after viral swab)
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.
4 secondary outcomes
RSV-related health care consumption and indirect costs in older adults
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Data will be collected at the last timepoint (30 days after viral swab)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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RSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Bont, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanne G Wildenbeest, MD, PhD (0031887563776, J.G.Wildenbeest@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burden of medically attended RSV infection in the Dutch primary care (time frame: Data will be collected at three timepoints (Day 0, Day 14 and Day 30 days after viral swab)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.