RESCEU Study, Defining the Burden of Disease of RSV in Older Adults

NCT03621930 | Unknown

• 1 other identifier: 116019-3
• Study Type: observational
• Target: 1,040
• Locations: 3 countries
• Sites: 3

Brief 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. 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.

Conditions

RSV Infection; Respiratory Syncytial Virus Infections; Bronchiolitis

Keywords

RESCEU (consortium); RSV; Respiratory Syncytial Virus

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  Data on worsening of cardiorespiratory status is collected during individual study participation of 1 year

• RSV-related mortality through the RSV season.

  Data on mortality is collected during individual study participation of 1 year

• Non-RSV related mortality through the RSV season.

  Data on mortality is collected during individual study participation of 1 year

• Health care costs for RSV-associated ARTI.

  Data on health care costs are collected during individual study participation of 1 year

• Health care costs for all-cause MA-ARTI.

  Data on health care costs are collected during individual study participation of 1 year

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• Willing and able to give written informed consent
• Willing and able to adhere to protocol-specified procedures

You may not qualify if:

• 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.

Sponsors & Collaborators

• UMC Utrecht: lead
• Universiteit Antwerpen: collaborator
• University of Oxford: collaborator

Study Sites (3)

University of Antwerp

Antwerp, Antwerpen, 2610, Belgium

Location

University Medical Centre Utrecht

Utrecht, 3584 CX, Netherlands

Location

University of Oxford

Oxford, OX3, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 37936699 DERIVED

• Mao 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.

  PMID: 35961055 DERIVED

• Zuurbier 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.

  PMID: 35134954 DERIVED

• Korsten 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.

  PMID: 34908153 DERIVED

• Korsten 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.

  PMID: 34904176 DERIVED

• Korsten 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.

  PMID: 33060153 DERIVED

Related Links

• RESCEU consortium webpage
• independent multinational research network with the mission to decrease the global burden of RSV infection

Biospecimen

Retention: SAMPLES WITH DNA

Blood: * Serum (RSV serology) * PaxGene (Transcriptome) * Whole blood (cellular immunity, DNA/genome-wide association study (GWAS), epigenetics) Swabs: * Nasopharyngeal swab (POCT) * Nasopharyngeal swab (viral multiplex PCR, deep sequence analysis) * Oropharyngeal swab (viral multiplex PCR, deep sequence analysis) * Nasopharyngeal swab (microbiome analysis)

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Bronchiolitis

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Bronchitis; Respiratory Tract Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Louis J Bont, MD, PhD

  University Medical Centre Utrecht, UMCU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD, PhD

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 9, 2018
• Study Start: August 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); GB (1); NL (1)