The RSV GOLD III study
- Conditions
- Respiratory syncytial virus and Influenza virus
- Registration Number
- NL-OMON24263
- Lead Sponsor
- MC Utrecht
- Brief Summary
not applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 4000
For this study, 2 groups (A and B) are distinguished:
•Group A: Suspected RSV (10 study sites): Children under 2 years of age admitted to an ICU or HDU who meet the WHO case definition extended SARI”. All children will be tested for RSV. At 3 study sites, children from group A will also be tested for influenza.
•Group B: Non-suspected RSV (3 study sites; 1 site per country): To determine whether the case definition extended SARI” is sufficiently sensitive for detecting children with severe RSV infection, we will also test children for RSV who do not meet the case definition at 3 study sites: children under 2 years of age admitted to an ICU or HDU who do not meet the WHO case definition extended SARI”.
Subjects can only participate when RSV or influenza samples are collected while admitted to the ICU or HDU at participating study sites. Subjects <4 days of age will be excluded.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the clinical, demographic and socioeconomic characteristics of RSV-positive children under 2 years of age who have been admitted with suspected RSV infection at ICUs or HDUs in GAVI eligible countries.
- Secondary Outcome Measures
Name Time Method