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

August 1, 2019 updated by: Louis Bont, UMC Utrecht

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:

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Actual)

1040

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerpen
      • Antwerp, Antwerpen, Belgium, 2610
        • University of Antwerp
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Centre Utrecht
  • United Kingdom
      • Oxford, United Kingdom, OX3
        • University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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 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.
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
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.
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
defined as pneumonia within 21 days after RSV infection and associated antibiotic use.
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
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
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.
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
Samples are collected at various timepoints during the one year study participation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

University of Oxford
Universiteit Antwerpen

Investigators

  • Principal Investigator: Louis J Bont, MD, PhD, University Medical Centre Utrecht, UMCU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116019-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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