RESCEU: Defining the Burden of RSV Disease

University of Oxford

Status: Active, not recruiting

Conditions: Respiratory Syncytial Virus Infections; RSV Infection

Treatments: Procedure: nasopharyngeal swab; Procedure: venepuncture

Study type: Observational

Funder types: Other

Identifiers

NCT03698084

2017/01

Details and patient eligibility

About

This observational study will determine the burden of RSV disease in at least 2000 healthy infants over 6 years until November 2026. The study will determine the incidence of acute respiratory tract infection (ARTI) associated with RSV, of medically attended ARTI and RSV related hospitalisation.

Mortality (RSV associated and all-cause) through all RSV seasons and the health care costs, resource use and Health Related Quality of Life will also be determined. The study also aims to determine important risk factors for RSV infection (by severity and healthcare utilisation.

Full description

Infants will be recruited into one of two cohorts:

Passive (around 1800 participants) - Demographic data will be collected at inclusion and a parental questionnaire at one year of age. Infants admitted to a hospital with an acute respiratory tract illness will be followed up to the age of 3 years or 6 years with additional consent.

Active (around 200 participants) - Demographic data, parental questionnaire and the following samples will be collected at inclusion; blood, nasopharyngeal swabs, urine and stool. During the infants first RSV season (Oct - May) weekly phone contact will monitor respiratory symptoms. Infants with respiratory symptoms associated with RSV (confirmed by point of care testing) will have further samples of blood, nasopharyngeal swabs, urine and stool collected at the time of infection and 7 weeks later. Infants in the active cohort will be followed up for up to 3 years or 6 years with additional consent.

Enrollment: 2,000 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy children, gestation age at least 37+0 weeks, born at participating centres.
• Written informed consent obtained from the mother.
• Parents able and willing to adhere to protocol-specified procedures (active cohort).

Exclusion criteria

• Major congenital defects or serious chronic illness (i.e. severe congenital heart and/or lung disease, genetic, immunologic and/or metabolic disorder).
• Gestational age of less than 37+0 weeks.
• Acute severe medical condition at moment of sampling (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 (by parental report).

Trial design

2,000 participants in 2 patient groups

Active

Description:

200 infants enrolled; family demographics collected and samples at day 5 (venepuncture, nasopharyngeal swab, urine and stool), actively followed up through their first RSV season for signs of respiratory symptoms. If respiratory symptoms are due to RSV infection (by point of care testing) samples as taken at day 5 are repeated at time of infection and again 7 weeks later. Annual questionnaire enquiring into respiratory illness, hospitalisations and family health and health quality of life, for up to 3 years.

Treatment:

Procedure: venepuncture

Procedure: nasopharyngeal swab

Passive

Description:

1800 infants enrolled; family demographics collected. Questionnaire follow up at 1 year of age enquiring into respiratory illness, hospitalisations and family health and health quality of life. If infant was hospitalised in first year of life, follow up will continue for up to 3 years.