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Recruiting NCT07698769

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis.
Who it may be relevant to
Registry conditions: Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines). Basic parameters: 0 months — 6 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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). This sample collection will be carried out specifically for the study of immunity. Innate immune mediators (type I, II and III IFNs) and key inflammatory molecules (IL-6, TNF-alpha, IL-10) will be quantified, and adaptive immunity will be analysed by measuring local immunoglobulin titres (IgG, A, M, subclasses and specific antibodies against the inactivated virus) from the nasopharyngeal swab and blood samples absorbed onto filter paper. A blood sample may also be offered to 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 (identification of the host's protein, cellular and transcriptomic response). Finally, the bacterial microbiome (16S RNA) and the soluble virome will be characterised by high-throughput sequencing.

Interventions

  • Biological 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 supplémentai

Primary outcome measures

  • Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines) [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

France · 3 centers
  • CHI Créteil — Créteil
  • CHU Necker — Paris
  • CHU Robert-Debré — Paris

Identifiers

NCT: NCT07698769 · 2024-A01208-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗