REspiratory Syncytial virus Consortium in EUrope (RESCEU)

Presumed risk factors and biomarkers for RSV-related severe disease and related sequelae.

Open to recruitment

Aims of the study

Primary

  • To establish biomarkers predictive of, or associated with, lower respiratory tract RSV infection and disease severity in infants.

Secondary

  • To establish biomarkers associated with sequelae following RSV infection in infants
  • To characterise the viral load and genetic sequence of RSV associated with mild and severe disease
  • To characterise the immune response to mild and severe RSV disease
  • To describe the transcriptomic, proteomic, metabolic and epigenetic signatures associates with RSV disease severity and/or respiratory sequelae
  • To biobank specimens for later analysis of respiratory/stool microbiome, genetic associations with severe RSV disease and/or respiratory sequelae
  • To determine health care costs, health care resource use, interruption of normal activities, and Health Related Quality of Life (HRQoL) in RSV-associated ARTI patients and their families

Inclusion Criteria

The participant may enter the study if ALL of the following apply:

  • 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
  • For Group 1 only: hospitalised with RSV ARTI for <48 hours at enrolment or within 96 hours of development or RSV ARTI 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

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

  • 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 stud

Infants should not be enrolled as healthy controls (Group 2) if they have any of the following criteria:

  • History of respiratory illness in the past 7 days