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

NCT03621930 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1040

Last updated 2019-08-05

No results posted yet for this study

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

Sponsors & Collaborators

  • Universiteit Antwerpen

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Louis J Bont, MD, PhD · University Medical Centre Utrecht, UMCU

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • Belgium
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621930 on ClinicalTrials.gov