RSV InfectionNCT03621930
RESCEU Study, Defining the Burden of Disease of RSV in Older Adults
An observational study of RSV Infection and Respiratory Syncytial Virus Infections, run by UMC Utrecht at 3 sites in 3 countries.
Trial summary
The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- RSV Infection, Respiratory Syncytial Virus Infections, Bronchiolitis
- How many people
- 1,040 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Aug 2017to 1 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort of approximately 1,000 older adults (≥60 years, including approximately 500 ≥75 years). Participants will be randomly recruited from the database of general practitioners in the following countries: the Netherlands (University Medical Centre Utrecht), Belgium (University of Antwerp) and United Kingdom (University of Oxford).
Who may be able to join
- Male and female adults ≥60 years of age (comorbidity, including chronic heart disease is not an exclusion criterion)
- Willing and able to give written informed consent
- Willing and able to adhere to protocol-specified procedures
Who cannot join
- Unable to perform the study procedures
- Current alcohol or drug abuse or history of unsuccessfully treated alcohol or drug abuse within the past year
- Dementia
- Life expectancy less than 1 year
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination (a more detailed description/list can be found in appendix 3 of the study protocol).
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to study participation. The use of topical, inhaled, and nasal glucocorticoids will be permitted (a more detailed description/list can be found in appendix 3 of the study protocol).
- Previous participation in this study or in a RSV interventional trial (vaccine, antivirals).
- Planned leave/holiday during the winter season of more than 1 month in total.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Older Adults in Europe.
The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. RSV causes severe disease in individuals at the extremes of the age spectrum and in high risk groups. It was estimated that RSV was associated with 34 million cases of acute respiratory tract infection (ARTI), 3.4 million ARTI hospitalizations and 55,000 to 199,000 deaths in children <5 years in 2005 worldwide. The estimated burden of disease in older adults is comparable with non-pandemic influenza A (for which a vaccine is available). These estimates were based on limited data and there is a substantial gap in knowledge on morbidity and associated healthcare and social costs in Europe. New vaccines and therapeutics against RSV are in development and could soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of RSV disease in young children and older adults in Europe, which is essential for stakeholders (governments, etc.) to take decisions about prophylaxis and treatment.
Objective:
Read more
To determine the burden of disease due to RSV in older adults.
Study design:
Prospective epidemiological, observational, multi-country, multicenter cohort study.
Study population:
Adults aged 60 years and up (n=1,000) of which approximately 50% is above 75 years of age.
Main study parameters/endpoints:
The primary endpoints of the study are;
- The incidence of RSV infection-associated ARTI.
- RSV associated medically attended (MA) ARTI.
- RSV related hospitalization.
Read the detailed description
In total, 1000 participants are recruited in three European countries (the Netherlands, Belgium and the United Kingdom). Participants, older adults above the age of 60 years, are recruited from general practitioners offices. Individual participants will be followed for one year (at least one winter season). For the individual participant the study procedures are described below:
Baseline visit:
Baseline visits are performed either at home or at the participating site before the start of the RSV season. The beginning of the season is to be determined per site in accordance to the local virologic surveillance reports. In general, baseline visits are performed between August and the beginning of October.
A questionnaire on demographic, social and clinical status is completed during this visit. Additionally, vital signs are recorded such as oxygen saturation, heart frequency and breathing frequency. During the baseline visit a blood sample (60 ml, serum, paxgene, whole blood) and nasopharyngeal swab (microbiome) will be collected.
Weekly follow-up during the RSV season:
From October until May participants are contacted weekly to check whether there are signs of a respiratory tract infection. If respiratory symptoms are present, the study team will perform a home visit or ask the participant to visit the site to perform a rapid Polymerase Chain Reaction (PCR)-based point of care test (POCT) for RSV using a nasopharyngeal swab. Additionally both an oro- and nasopharyngeal swab are collected for standard PCR, vital signs are recorded. Participants are asked to complete a daily dairy on respiratory symptoms, health care use and quality of life during 28 days from the moment of infection. If symptoms are not present anymore for two consecutive days, the participant can stop completing the diary.
In case of a positive RSV infection, additional sampling is performed by the study team. This consists of a nasopharyngeal swab (microbiome) and blood (Serum/PaxGene/whole blood). The same materials (minus serum and PaxGene sample) are collected again in convalescence (1-2 weeks after infection).
End of season visit:
At the end of the RSV season (May-June), again sampling is performed combined with recording vital signs. Samples collected are; blood (serum/PaxGene) and a nasopharyngeal swab (microbiome). In addition, a questionnaire will completed on respiratory symptoms, health care use, social status and quality of life.
- Keywords
- RESCEU (consortium), RSV, Respiratory Syncytial Virus
- Medical subject headings
- Respiratory Syncytial Virus Infections, Bronchiolitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed RSV infection (incidence of RSV infection).
The main outcome of the study is to determine the burden of RSV in the older adult population. Therefore the incidence rate of all RSV in the overall study population of older patients is investigated, including medically attended RSV infection-associated ARTI in both inpatients and outpatients. Nasal swabs are collected by the study team in case of a respiratory infection and tested with RT-PCR for presence of RSV. The incidence of RSV is calculated by dividing the number of RSV positive infections by the total number of study participants. The number of RSV positive infections divided by the total number of infections is calculated as well.
Measured: Data is collected during the RSV season by weekly contact and viral swab diagnostics for RSV in case of respiratory infection. Medically attended RSV will be recorded throughout the one year follow-up.
Secondary outcomes (8)
The incidence rate of all-cause MA-ARTI or events leading to worsening of cardiorespiratory status (based on questionnaires at baseline and after one year of follow-up).
worsening of cardiorespiratory status is monitored using the questionnaire data collected at baseline and follow-up after 1 year. This includes questions on medication usage, new chronic diagnoses and doctor visits for all cause respiratory illness.
Measured: Data on worsening of cardiorespiratory status is collected during individual study participation of 1 year
RSV-related mortality through the RSV season.
Mortality through the RSV season. RSV-associated deaths are recorded and verified by the presence of an active infection with PCR proven RSV-infection around the time of death. Data is recorded in questionnaires during and after the winter season and based on hospital case-report forms (CRF's) in case of in-hospital death.
Measured: Data on mortality is collected during individual study participation of 1 year
Non-RSV related mortality through the RSV season.
Mortality through the RSV season. All-cause mortality is recorded. Data is recorded in questionnaires during and after the winter season and based on hospital case-report forms (CRF's) in case of in-hospital death.
Measured: Data on mortality is collected during individual study participation of 1 year
Health care costs for RSV-associated ARTI.
Health care cost are examined with regard to resource usage such as hospitalization, hospital duration, incidence and duration of intensive care unit stay, supplemental oxygen use, antibiotic and antiviral use and number of outpatient visits (e.g., ER visit, physician office/outpatient visits). The costs of these resource use are calculated to determine the health care cost associated with an RSV infection.
Measured: Data on health care costs are collected during individual study participation of 1 year
Health care costs for all-cause MA-ARTI.
Health care cost for all-cause medically attended ARTI are examined with regard to resource usage such as hospitalization, hospital duration, incidence and duration of intensive care unit stay, supplemental oxygen use, antibiotic and antiviral use and number of outpatient visits (e.g., ER visit, physician office/outpatient visits).The costs of these resource use are calculated to determine the health care cost associated with an RSV infection.
Measured: Data on health care costs are collected during individual study participation of 1 year
The incidence rate of RSV-associated secondary bacterial pneumonia events
defined as pneumonia within 21 days after RSV infection and associated antibiotic use.
Measured: Data on the incidence of pneumonia are collected during individual study participation of 1 year
Change in frailty over the course of study using the Groningen Frailty indicator (GFI) questionnaire.
Frailty is assessed using the Groningen Frailty Indicator questionnaire which is included in the baseline and 1 year follow-up questionnaire. The GFI is a 15-item screening instrument to determine the level of frailty, which is available in a professional and self-report version. It measures the loss of functions and resources in 4 domains: physical (mobility functions, multiple health problems, physical fatigue, vision, hearing), cognitive (cognitive dysfunction), social (emotional isolation), and psychological (depressed mood and feelings of anxiety). All answer categories were dichotomized and a score of 1 indicates a problem or dependency. The range of the GFI score is 0 to 15. Geriatric experts agreed that a score of 4 or higher represents moderate to severe frailty
Measured: Data on the change in frailty is collected during individual study participation of 1 year
Sample collection for biomarker analysis to investigate possible biomarkers which are predictive of severe or complicated RSV disease in older adults
Blood sampling (serum/paxgene/whole blood) as well as viral and microbiome sampling using naso-/oropharyngeal swabs is performed to collect biomaterials for biomarker research on RSV severity and susceptibility
Measured: Samples are collected at various timepoints during the one year study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Aug 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Oxford
- Responsible party
- Principal investigator, Louis Bont, UMC Utrecht
- Investigators
- Louis J Bont, MD, PhD, Principal investigator, University Medical Centre Utrecht, UMCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621930
- Sponsor's protocol ID
- 116019-3
- Status last verified
- Aug 2019
- First submitted
- 18 Jul 2018
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salaun B, De Smedt J, Vernhes C, Moureau A, Oner D, Bastian AR, Janssens M, Balla-Jhagjhoorsingh S, Aerssens J, Lambert C, Coenen S, Butler CC, Drysdale SB, Wildenbeest JG, Pollard AJ, Openshaw PJM, Bont L. T cells, more than antibodies, may prevent symptoms developing from respiratory syncytial virus infections in older adults. Front Immunol. 2023 Oct 13;14:1260146. doi: 10.3389/fimmu.2023.1260146. eCollection 2023.
PubMed 37936699Mao Z, Li X, Korsten K, Bont L, Butler C, Wildenbeest J, Coenen S, Hens N, Bilcke J, Beutels P; RESCEU Investigators. Economic Burden and Health-Related Quality of Life of Respiratory Syncytial Virus and Influenza Infection in European Community-Dwelling Older Adults. J Infect Dis. 2022 Aug 12;226(Suppl 1):S87-S94. doi: 10.1093/infdis/jiac069.
PubMed 35961055Zuurbier RP, Korsten K, Verheij TJM, Butler C, Adriaenssens N, Coenen S, Gruselle O, Vantomme V, van Houten MA, Bont LJ, Wildenbeest JG; REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Investigators. Performance Assessment of a Rapid Molecular Respiratory Syncytial Virus Point-of-Care Test: A Prospective Community Study in Older Adults. J Infect Dis. 2022 Aug 12;226(Suppl 1):S63-S70. doi: 10.1093/infdis/jiab600.
PubMed 35134954Korsten K, Adriaenssens N, Coenen S, Butler CC, Pircon JY, Verheij TJM, Bont LJ, Wildenbeest JG; RESCEU Investigators. Contact With Young Children Increases the Risk of Respiratory Infection in Older Adults in Europe-the RESCEU Study. J Infect Dis. 2022 Aug 12;226(Suppl 1):S79-S86. doi: 10.1093/infdis/jiab519.
PubMed 34908153Korsten K, Adriaenssens N, Coenen S, Butler CC, Verheij TJM, Bont LJ, Wildenbeest JG; RESCEU Investigators. World Health Organization Influenza-Like Illness Underestimates the Burden of Respiratory Syncytial Virus Infection in Community-Dwelling Older Adults. J Infect Dis. 2022 Aug 12;226(Suppl 1):S71-S78. doi: 10.1093/infdis/jiab452.
PubMed 34904176Korsten K, Adriaenssens N, Coenen S, Butler C, Ravanfar B, Rutter H, Allen J, Falsey A, Pircon JY, Gruselle O, Pavot V, Vernhes C, Balla-Jhagjhoorsingh S, Oner D, Ispas G, Aerssens J, Shinde V, Verheij T, Bont L, Wildenbeest J; RESCEU investigators. Burden of respiratory syncytial virus infection in community-dwelling older adults in Europe (RESCEU): an international prospective cohort study. Eur Respir J. 2021 Apr 1;57(4):2002688. doi: 10.1183/13993003.02688-2020. Print 2021 Apr.
PubMed 33060153
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Older Adults in Europe.
- ClinicalTrials.gov ID
- NCT03621930
- Acronym / sponsor ID
- 116019-3
- Keywords
- RESCEU (consortium), RSV, Respiratory Syncytial Virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Oxford
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 9 Aug 2018 (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.
The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. RSV causes severe disease in individuals at the extremes of the age spectrum and in high risk groups. It was estimated that RSV was associated with 34 million cases of acute respiratory tract infection (ARTI), 3.4 million ARTI hospitalizations and 55,000 to 199,000 deaths in children <5 years in 2005 worldwide. The estimated burden of disease in older adults is comparable with non-pandemic influenza A (for which a vaccine is available). These estimates were based on limited data and there is a substantial gap in knowledge on morbidity and associated healthcare and social costs in Europe. New vaccines and therapeutics against RSV are in development and could soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of RSV disease in young children and older adults in Europe, which is essential for stakeholders (governments, etc.) to take decisions about prophylaxis and treatment.
Objective:
To determine the burden of disease due to RSV in older adults.
Study design:
Prospective epidemiological, observational, multi-country, multicenter cohort study.
Study population:
Adults aged 60 years and up (n=1,000) of which approximately 50% is above 75 years of age.
Main study parameters/endpoints:
The primary endpoints of the study are;
- The incidence of RSV infection-associated ARTI.
- RSV associated medically attended (MA) ARTI.
- RSV related hospitalization.
Detailed description
In total, 1000 participants are recruited in three European countries (the Netherlands, Belgium and the United Kingdom). Participants, older adults above the age of 60 years, are recruited from general practitioners offices. Individual participants will be followed for one year (at least one winter season). For the individual participant the study procedures are described below:
Baseline visit:
Baseline visits are performed either at home or at the participating site before the start of the RSV season. The beginning of the season is to be determined per site in accordance to the local virologic surveillance reports. In general, baseline visits are performed between August and the beginning of October.
A questionnaire on demographic, social and clinical status is completed during this visit. Additionally, vital signs are recorded such as oxygen saturation, heart frequency and breathing frequency. During the baseline visit a blood sample (60 ml, serum, paxgene, whole blood) and nasopharyngeal swab (microbiome) will be collected.
Weekly follow-up during the RSV season:
From October until May participants are contacted weekly to check whether there are signs of a respiratory tract infection. If respiratory symptoms are present, the study team will perform a home visit or ask the participant to visit the site to perform a rapid Polymerase Chain Reaction (PCR)-based point of care test (POCT) for RSV using a nasopharyngeal swab. Additionally both an oro- and nasopharyngeal swab are collected for standard PCR, vital signs are recorded. Participants are asked to complete a daily dairy on respiratory symptoms, health care use and quality of life during 28 days from the moment of infection. If symptoms are not present anymore for two consecutive days, the participant can stop completing the diary.
In case of a positive RSV infection, additional sampling is performed by the study team. This consists of a nasopharyngeal swab (microbiome) and blood (Serum/PaxGene/whole blood). The same materials (minus serum and PaxGene sample) are collected again in convalescence (1-2 weeks after infection).
End of season visit:
At the end of the RSV season (May-June), again sampling is performed combined with recording vital signs. Samples collected are; blood (serum/PaxGene) and a nasopharyngeal swab (microbiome). In addition, a questionnaire will completed on respiratory symptoms, health care use, social status and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of approximately 1,000 older adults (≥60 years, including approximately 500 ≥75 years). Participants will be randomly recruited from the database of general practitioners in the following countries: the Netherlands (University Medical Centre Utrecht), Belgium (University of Antwerp) and United Kingdom (University of Oxford).
Key inclusion criteria (3 listed)
- Male and female adults ≥60 years of age (comorbidity, including chronic heart disease is not an exclusion criterion)
- Willing and able to give written informed consent
- Willing and able to adhere to protocol-specified procedures
Key exclusion criteria (8 listed)
- Unable to perform the study procedures
- Current alcohol or drug abuse or history of unsuccessfully treated alcohol or drug abuse within the past year
- Dementia
- Life expectancy less than 1 year
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination (a more detailed description/list can be found in appendix 3 of the study protocol).
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
Number of participants with a Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed RSV infection (incidence of RSV infection).
Time frame: Data is collected during the RSV season by weekly contact and viral swab diagnostics for RSV in case of respiratory infection. Medically attended RSV will be recorded throughout the one year follow-up.
The main outcome of the study is to determine the burden of RSV in the older adult population. Therefore the incidence rate of all RSV in the overall study population of older patients is investigated, including medically attended RSV infection-associated ARTI in both inpatients and outpatients. Nasal swabs are collected by the study team in case of a respiratory infection and tested with RT-PCR for presence of RSV. The incidence of RSV is calculated by dividing the number of RSV positive infections by the total number of study participants. The number of RSV positive infections divided by the total number of infections is calculated as well.
8 secondary outcomes
The incidence rate of all-cause MA-ARTI or events leading to worsening of cardiorespiratory status (based on questionnaires at baseline and after one year of follow-up).
Time frame: Data on worsening of cardiorespiratory status is collected during individual study participation of 1 year
RSV-related mortality through the RSV season.
Time frame: Data on mortality is collected during individual study participation of 1 year
Non-RSV related mortality through the RSV season.
Time frame: Data on mortality is collected during individual study participation of 1 year
Health care costs for RSV-associated ARTI.
Time frame: Data on health care costs are collected during individual study participation of 1 year
Health care costs for all-cause MA-ARTI.
Time frame: Data on health care costs are collected during individual study participation of 1 year
The incidence rate of RSV-associated secondary bacterial pneumonia events
Time frame: Data on the incidence of pneumonia are collected during individual study participation of 1 year
Change in frailty over the course of study using the Groningen Frailty indicator (GFI) questionnaire.
Time frame: Data on the change in frailty is collected during individual study participation of 1 year
Sample collection for biomarker analysis to investigate possible biomarkers which are predictive of severe or complicated RSV disease in older adults
Time frame: Samples are collected at various timepoints during the one year study participation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Derived from this study: PubMed 37936699Salaun B, De Smedt J, Vernhes C, Moureau A, Oner D, Bastian AR, Janssens M, Balla-Jhagjhoorsingh S, Aerssens J, Lambert C, Coenen S, Butler CC, Drysdale SB, Wildenbeest JG, Pollard AJ, Openshaw PJM, Bont L. T cells, more than antibodies, may prevent symptoms developing from respiratory syncytial virus infections in older adults. Front Immunol. 2023 Oct 13;14:1260146. doi: 10.3389/fimmu.2023.1260146. eCollection 2023.
- Derived from this study: PubMed 35961055Mao Z, Li X, Korsten K, Bont L, Butler C, Wildenbeest J, Coenen S, Hens N, Bilcke J, Beutels P; RESCEU Investigators. Economic Burden and Health-Related Quality of Life of Respiratory Syncytial Virus and Influenza Infection in European Community-Dwelling Older Adults. J Infect Dis. 2022 Aug 12;226(Suppl 1):S87-S94. doi: 10.1093/infdis/jiac069.
- Derived from this study: PubMed 35134954Zuurbier RP, Korsten K, Verheij TJM, Butler C, Adriaenssens N, Coenen S, Gruselle O, Vantomme V, van Houten MA, Bont LJ, Wildenbeest JG; REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Investigators. Performance Assessment of a Rapid Molecular Respiratory Syncytial Virus Point-of-Care Test: A Prospective Community Study in Older Adults. J Infect Dis. 2022 Aug 12;226(Suppl 1):S63-S70. doi: 10.1093/infdis/jiab600.
- Derived from this study: PubMed 34908153Korsten K, Adriaenssens N, Coenen S, Butler CC, Pircon JY, Verheij TJM, Bont LJ, Wildenbeest JG; RESCEU Investigators. Contact With Young Children Increases the Risk of Respiratory Infection in Older Adults in Europe-the RESCEU Study. J Infect Dis. 2022 Aug 12;226(Suppl 1):S79-S86. doi: 10.1093/infdis/jiab519.
- Derived from this study: PubMed 34904176Korsten K, Adriaenssens N, Coenen S, Butler CC, Verheij TJM, Bont LJ, Wildenbeest JG; RESCEU Investigators. World Health Organization Influenza-Like Illness Underestimates the Burden of Respiratory Syncytial Virus Infection in Community-Dwelling Older Adults. J Infect Dis. 2022 Aug 12;226(Suppl 1):S71-S78. doi: 10.1093/infdis/jiab452.
- Derived from this study: PubMed 33060153Korsten K, Adriaenssens N, Coenen S, Butler C, Ravanfar B, Rutter H, Allen J, Falsey A, Pircon JY, Gruselle O, Pavot V, Vernhes C, Balla-Jhagjhoorsingh S, Oner D, Ispas G, Aerssens J, Shinde V, Verheij T, Bont L, Wildenbeest J; RESCEU investigators. Burden of respiratory syncytial virus infection in community-dwelling older adults in Europe (RESCEU): an international prospective cohort study. Eur Respir J. 2021 Apr 1;57(4):2002688. doi: 10.1183/13993003.02688-2020. Print 2021 Apr.
- RESCEU consortium webpageLink provided by the sponsor.
- independent multinational research network with the mission to decrease the global burden of RSV infectionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 J Bont, MD, PhD principal investigator
University Medical Centre Utrecht, UMCU
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection and Respiratory Syncytial Virus Infections, run by UMC Utrecht at 3 sites in 3 countries.
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 3 inclusion and 8 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Netherlands, United Kingdom. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed RSV infection (incidence of RSV infection). (time frame: Data is collected during the RSV season by weekly contact and viral swab diagnostics for RSV in case of respiratory infection. Medically attended RSV will be recorded throughout the one year follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621930, which also lists 6 linked publications.
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 5 Aug 2019.