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

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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age0-6

SponsorCentre Hospitalier Intercommunal Creteil

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Written consent to take part in the study

Registered with a social security scheme

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

Disqualifiers

Refusal to participate by the legal representative

Administration of palivizumab

Maternal vaccination against RSV.

Trial population

Among children aged 6 months or younger included in the ENVIE study, the ENVIE\_ancillaire study will be offered to those with RSV infection or to the control group.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: Case1 intervention

Group B: Control group1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Intercommunal Creteil

Lead sponsor

Source ClinicalTrials.gov

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