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ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment
Sponsor: Centre Hospitalier Intercommunal Creteil
Summary
Among children aged ≤ 6 months included in the ENVIE study, the ENVIE\_ancillaire study will be offered to cases of RSV infection or to controls. The study involves a nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip sample (dextro type). These samples will be collected specifically for the purpose of studying immunity. A blood sample may also be requested for children weighing ≥5 kg who are included in the ENVIE\_ancillaire study. The purpose of this sample collection will be to conduct an advanced immunological study
Key Details
Gender
All
Age Range
0 Months - 6 Months
Study Type
OBSERVATIONAL
Enrollment
110
Start Date
2024-12-05
Completion Date
2026-12-05
Last Updated
2026-07-13
Healthy Volunteers
Not specified
Conditions
Interventions
a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis
Once those with parental authority have confirmed their willingness for their child to take part in the research and written consent has been obtained, the following samples may be collected: * A nasopharyngeal swab * A 'dextro' blood sample with a blot on filter paper. The nasopharyngeal samples and blotting papers will be stored at -20°C (or -80°C if possible) and transported to the Pasteur Institute as soon as possible (just-in-time). il sera possible de proposer un prélèvement supplémentaire dans le cadre d'une étude immunologique avancée, chez les nourrissons ≥ 5 kg. Ce prélèvement comprend : * Un tube hépariné pour plasmatèque et cellulotèque : 5 mL * Un tube PAX gene pediatrique pour RNAtèque : 0,5 mL
Locations (3)
CHI Créteil
Créteil, France
CHU Necker
Paris, France
CHU Robert-Debré
Paris, France