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

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 design

Treatments tested in this trial

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

Treatment groups

110 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Centre Hospitalier Intercommunal Creteil

Lead sponsor

Source ClinicalTrials.gov