Trials / Active Not Recruiting
Active Not RecruitingNCT03698084
RESCEU: Defining the Burden of RSV Disease
REspiratory Syncytial Virus Consortium in EUrope (RESCEU) Study: Defining the Burden of Respiratory Syncytial Virus (RSV) Disease.
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- University of Oxford · Academic / Other
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | venepuncture | sample collection for analysis |
| PROCEDURE | nasopharyngeal swab | sample collection for analysis |
Timeline
- Start date
- 2017-09-05
- Primary completion
- 2026-11-30
- Completion
- 2026-11-30
- First posted
- 2018-10-05
- Last updated
- 2022-10-27
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03698084. Inclusion in this directory is not an endorsement.