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RESCEU Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Europe in Infants

NCT03627572 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2021-06-03

No results posted yet for this study

Summary

The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) effort 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. 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 will soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of disease RSV 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 young children.

Study design:

Prospective epidemiological, observational, multi-country, multicenter cohort study.

Study population:

Birth cohort of healthy infants (follow-up from birth until the age of 3 years maximum):

* Passive birth cohort (n=9,000).
* Active birth cohort (n=1,000).

Main study parameters/endpoints:

The primary endpoint of the study is the incidence of RSV infection-associated ARTI, RSV associated medically attended (MA) ARTI (active birth cohort) and RSV related hospitalization (passive birth cohort) in infants (\< 1 year) during 3 RSV seasons. In addition, a major secondary endpoint is RSV attributable burden of wheezing.

Conditions

  • RSV Infection
  • Respiratory Syncytial Virus Infections
  • RSV Bronchiolitis

Interventions

OTHER

No intervention

Not applicable (no intervention)

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • University of Edinburgh

    collaborator OTHER

  • University of Turku

    collaborator OTHER

  • Servicio Gallego de Salud

    collaborator OTHER_GOV

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Louis Bont, Prof. Dr. · University Medical Centre Utrecht (UMCU)

Eligibility

Max Age
2 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Finland
  • Netherlands
  • Spain
  • 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 NCT03627572 on ClinicalTrials.gov