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

NCT03627572 | Unknown

• 1 other identifier: 116019-1
• Study Type: observational
• Target: 10,000
• Locations: 4 countries
• Sites: 5

Brief 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

Keywords

RESCEU (consortium); Burden of Disease

Outcome Measures

Primary Outcomes (3)

• Number of participants with a Medically attended RSV acute lower respiratory tract infection (MA-RSV-ALRI) based on a positive RT-PCR for RSV who visit a clinician during the RSV-ALRI.

  Lower respiratory tract infection proven to be caused by RSV for which medical consultation (general practitioner/specialist/hospitalization) is required. RSV infection is confirmed using RT-PCR from a nasal swab collected by the study team in the active cohort in case of respiratory infection. In the passive cohort, this information is collected from medical data from the hospital in case of hospitalization.

  In the active cohort during the RSV season (Oct-May), for all participants after 1 year (questionnaire)

• Number of participants with a RSV hospitalization (hospitalization with RT-PCR confirmed RSV).

  Hospitalization for a respiratory tract infection proven to be caused by RSV. This information is collected from the hospital data. RSV must be confirmed by RT-PCR.

  In the active cohort during the RSV season (Oct-May), for all participants after 1 year (questionnaire)

• Number of participants with an RSV infection

  Incidence of RSV outside of the medical setting (active cohort only). When participants experience respiratory symptoms, the study team plans a visit to perform RSV diagnostics (nasopharyngeal swab).

  Active cohort only, during the RSV season (Oct-May)

Secondary Outcomes (11)

• RSV-related wheeze incidence

  The incidence of wheeze will be determined by annual questionnaires at age 1 year, 2 years and 3 years (active cohort and all children hospitalized for ARTI) maximum or till end of study.

• RSV related wheeze sequelae

  Severity of wheeze will be determined by annual questionnaires at age 1 year, 2 years and 3 years (active cohort and all children hospitalized for ARTI) maximum or till end of study.

• All cause MA-ARTI

  annual questionnaire at age 1 year (all participants)

• Effect of RSV on health care cost

  Questionnaires during the first year of life (all), and up to 3 years of age (active cohort, RSV+ cases)

• Effect of all-cause ARTI on health care cost

  Questionnaires during the first year of life (all), and up to 3 years of age (active cohort)

Study Arms (2)

Active cohort (N=1000)

Participants in this group will complete questionnaires at baseline (birth) and after 1-2-3 years. At baseline samples will be collected (blood/nasopharyngeal/urine/feces/buccal). During the RSV season(Oct-May) active sampling for RSV will be done when infants experience a respiratory infection.

Other: No intervention

Passive cohort (N=9000)

Parents who agree with participation in the study will be asked to fill out a questionnaire at inclusion in the first week(s) after birth and at age one year. Only children who were admitted to the hospital for ARTI during the first year of life will be followed up to the age of maximum 3 years by yearly questionnaires.

Other: No intervention

Interventions

No intervention OTHER

Not applicable (no intervention)

Active cohort (N=1000); Passive cohort (N=9000)

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Birth cohort of 10,000 healthy term infants of the general population including a nested (active) cohort of 1,000 healthy term infants. Subjects will be recruited from maternity wards during the first days after birth in the following countries: the Netherlands (UMCU), United Kingdom (UEDIN, UOXF), Spain (Sergas) and Finland (TUH).

You may qualify if:

• Healthy\* children, gestation age at least 37+0, born at participating centers.
• Written informed consent obtained from parents.
• Parents ability and willingness to adhere to protocol-specified procedures (active cohort).

You may not qualify if:

• History of clinically significant medical illness including but not limited to, cardiovascular, respiratory, renal, gastrointestinal, haematologic, neurological, endocrine, immunological, musculoskeletal, oncological or congenital disorders, as judged by the investigator. Specifically excluded examples include, but are not limited to:
• Immunosuppressed states
• Bronchopulmonary dysplasia/chronic lung disease of infancy
• (clinically significant) Congenital heart disease
• Down's syndrome
• Gestational age of less than 37+0 weeks.
• Acute severe medical condition at moment of heel prick (e.g. sepsis, severe asphyxia, for which the child is admitted to the hospital).
• Child in care.
• Parents not able to understand and communicate in the local language.
• Living outside catchment area of study sites.
• Mother vaccinated against RSV during pregnancy.

Sponsors & Collaborators

• UMC Utrecht: lead
• University of Oxford: collaborator
• University of Edinburgh: collaborator
• University of Turku: collaborator
• Servicio Gallego de Salud: collaborator

Study Sites (5)

Varsinais-Suomen sairaanhoitopiirin kuntayhtymä (Turku University Hospital)

Turku, FI-20520, Finland

Location

University Medical Centre Utrecht

Utrecht, 3584 CX, Netherlands

Location

Servicio Galego de Saúde (SERGAS)

Santiago de Compostela, 15706, Spain

Location

University of Edinburgh

Edinburgh, United Kingdom

Location

University of Oxford, Oxford Vaccine Group

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (5)

• Hak SF, Venekamp RP, Billard MN, Cianci D, Van Houten MA, Pollard AJ, Heikkinen T, Cunningham S, Millar M, Martinon-Torres F, Dacosta-Urbieta A, Bont LJ, Wildenbeest JG; PROMISE Investigators. Antibiotic use attributable to RSV infections during infancy-an international prospective birth cohort study. J Antimicrob Chemother. 2025 Jul 1;80(7):1803-1812. doi: 10.1093/jac/dkaf123.

  PMID: 40343736 DERIVED

• Hak SF, Venekamp RP, Billard MN, van Houten MA, Pollard AJ, Heikkinen T, Cunningham S, Millar M, Martinon-Torres F, Dacosta-Urbieta A, Bont LJ, Wildenbeest JG; PROMISE Investigators. Substantial Burden of Nonmedically Attended RSV Infection in Healthy-Term Infants: An International Prospective Birth Cohort Study. J Infect Dis. 2024 Mar 1;229(Supplement_1):S40-S50. doi: 10.1093/infdis/jiad477.

  PMID: 38424744 DERIVED

• Wildenbeest JG, Billard MN, Zuurbier RP, Korsten K, Langedijk AC, van de Ven PM, Snape MD, Drysdale SB, Pollard AJ, Robinson H, Heikkinen T, Cunningham S, O'Neill T, Rizkalla B, Dacosta-Urbieta A, Martinon-Torres F, van Houten MA, Bont LJ; RESCEU Investigators. The burden of respiratory syncytial virus in healthy term-born infants in Europe: a prospective birth cohort study. Lancet Respir Med. 2023 Apr;11(4):341-353. doi: 10.1016/S2213-2600(22)00414-3. Epub 2022 Nov 10.

  PMID: 36372082 DERIVED

• Wildenbeest JG, Zuurbier RP, Korsten K, van Houten MA, Billard MN, Derksen-Lazet N, Snape MD, Drysdale SB, Robinson H, Pollard AJ, Heikkinen T, Cunningham S, Leach A, Martinon-Torres F, Rodriguez-Tenreiro Sanchez C, Gomez-Carballa A, Bont LJ; RESCEU Investigators. Respiratory Syncytial Virus Consortium in Europe (RESCEU) Birth Cohort Study: Defining the Burden of Infant Respiratory Syncytial Virus Disease in Europe. J Infect Dis. 2020 Oct 7;222(Suppl 7):S606-S612. doi: 10.1093/infdis/jiaa310.

  PMID: 32794574 DERIVED

• Lin GL, Golubchik T, Drysdale S, O'Connor D, Jefferies K, Brown A, de Cesare M, Bonsall D, Ansari MA, Aerssens J, Bont L, Openshaw P, Martinon-Torres F, Bowden R, Pollard AJ; RESCEU Investigators. Simultaneous Viral Whole-Genome Sequencing and Differential Expression Profiling in Respiratory Syncytial Virus Infection of Infants. J Infect Dis. 2020 Oct 7;222(Suppl 7):S666-S671. doi: 10.1093/infdis/jiaa448.

  PMID: 32702120 DERIVED

Related Links

• RESCEU website

Biospecimen

Retention: SAMPLES WITH DNA

* Blood sample (serum/paxgene/whole blood) * Buccal sample * Nasopharyngeal sample (microbiome) * Nasopharyngeal sample (viral testing) * Urine sample * Stool sample

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Louis Bont, Prof. Dr.

  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: Principle investigator, Pediatric infectious disease specialist

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 13, 2018
• Study Start: July 21, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 3, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); ES (1); GB (2); FI (1)