ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Eligibility
Primary outcome measure(s)
- Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines) — Baseline
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| CHI Créteil | Créteil | France | Recruiting |
| CHU Necker | Paris | France | Recruiting |
| CHU Robert-Debré | Paris | France | Recruiting |
More Centre Hospitalier Intercommunal Creteil trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07698769 on ClinicalTrials.gov ↗ ← All trials in France