No registrations found.
ID
Source
Brief title
Health condition
Respiratory syncytial virus and Influenza virus
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
-
Background summary
The main objective of this study is to describe the clinical, demographic and socioeconomic characteristics of RSV-positive children under 2 years of age who have been admitted with suspected RSV at intensive care units (ICUs) and high dependency units (HDUs) in GAVI eligible countries. One of the secondary objectives of this study is to collect similar data on influenza infection in the target population as a comparator disease. We will perform an international, prospective, observational multicenter study in 10 countries at 10 ICUs or HDUs during 2 RSV seasons. Children who meet the inclusion criteria will be tested for RSV (all 10 sites) and influenza (at 3 sites). In addition, the study will be performed in 2 pediatric ICUs from the Netherlands to allow for a comparison with a high-income country. A molecular point-of-care (POC) device will be provided by University Medical Centre Utrecht (UMCU) to all LMIC study sites. We will collect clinical and demographic characteristics of tested children using a questionnaire.
Study objective
This study will collect data describing the clinical, demographic and socioeconomic characteristics of individual RSV-positive children under 2 years of age who have been admitted with suspected RSV infection at ICUs or HDUs in GAVI eligible countries.
Study design
• March 15, 2021: Start of data collection (first patient in).
• September 1, 2023: End of data collection.
• Methods for data collection: point-of-care RSV and influenza testing, for RSV and influenza-positive patients filling out case report form and parental questionnaire.
Intervention
POC RSV test and 2 questionnaires
Inclusion criteria
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”.
Exclusion criteria
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9519 |
| Other | METC UMCU : METC 20-536 |