REspiratory Syncytial virus Consortium in EUrope (RESCEU): Presumed risk factors and biomarkers for RSV-related severe disease and related sequelae.

Recruiting

• Conditions: Respiratory Syncytial Virus; RSV; RS-virus; 10024970

• Registration Number: NL-OMON52425
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

• Parent/carer of infant is willing and able to give informed consent for
participation in the study.
• Male or female, and less than 12 months of age at enrolment.
• Parent has a telephone.
• Hospitalized for <48 hours at enrolment or within 96hrs of onset of illness
(for those not admitted).*
• Live near enough to a participating study centre for the 6-8 week home
visit/hospital appointment to be feasible.*, * not applicable for healthy
control infants (group 2)

Inclusion criteria - Extension until 6 years of age
- Participants from Group 1a (previously healthy infants hopsitalized with RSV)
and Group 1b (previously healthy with RSV infection that did not require
admission).
- Informed consent obtained from parents

Exclusion Criteria

• History of concurrent clinically significant medical illness (not directly
attributable to RSV infection) including but not limited to, cardiovascular,
respiratory, renal, gastrointestinal, haematology, neurology, endocrinology,
immunology, musculoskeletal, oncological or congenital disorders, as judged by
the investigator*
Specifically excluded examples include, but are not limited to:
o Immunosuppressed states
o Bronchopulmonary dysplasia/chronic lung disease of infancy
o Congenital heart disease
o Down*s syndrome
• Prematurity, as defined as gestational age <37 weeks at birth.*
• History of receipt of medication to treat RSV infection (e.g. ribavirin).
• Prior exposure to an RSV investigational vaccine or medication.
• History of receipt of immunoglobulin or monoclonal antibodies (including
palivizumab).
• Use of steroids or montelukast within 7 days of enrolment in the study.
• Parents not able to communicate in the local language or English.

* Inclusion criteria (and/or) for exploratory group of RSV infected infants
with comorbidity (group 1c and 1d)

Exclusion criteria - Extension study until 6 years of age:
- None

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is disease severity of RSV infection in the first year of<br /><br>life.</p><br>