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Recruiting Observational

ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment

NCT07698769 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-12-05
Last updated
2026-07-13

Condition(s) studied

Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)

Investigational drug(s) / intervention(s)

a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis

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

Sex
ALL
Min age
0 Months
Max age
6 Months
Healthy volunteers
No
Inclusion Criteria: * Written consent to take part in the study * Registered with a social security scheme Cases: * Children aged 6 months or under included in the ENVIE study. Treated for bronchiolitis caused by RSV * Admitted to hospital following a visit to the paediatric A\&E department Control group: Children aged 6 months or under included in the ENVIE study. Admitted to a standard ward or a Short-Stay Unit, or having attended the paediatric A\&E department For one of the following reasons: * Febrile urinary tract infection, without acute ENT or respiratory symptoms * Acute gastroenteritis, without acute ENT or respiratory symptoms * Infant colic without fever, without ENT or acute respiratory condition * Weight stagnation or feeding difficulties without fever, without acute ENT or respiratory symptoms * Neonatal jaundice without fever, without acute ENT or respiratory symptoms * Unexplained crying without fever, without acute ENT or respiratory symptoms * Head injury, without acute ENT or respiratory symptoms * Admitted for acute surgical conditions, without fever, without acute ENT or respiratory symptoms * Nappy rash, without fever, without acute ENT or respiratory symptoms * Fracture, without fever, without acute ENT or respiratory symptoms. Exclusion Criteria: * Refusal to participate by the legal representative * Administration of palivizumab * Maternal vaccination against RSV.

Primary outcome measure(s)

  • Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines) — Baseline

Trial sites (3)

FacilityCityRegionStatus
CHI Créteil Créteil France Recruiting
CHU Necker Paris France Recruiting
CHU Robert-Debré Paris France Recruiting
Official registry record

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