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RecruitingNCT07698769

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

Sponsor

Centre Hospitalier Intercommunal Creteil

Enrollment

110 participants

Start Date

Dec 5, 2024

Study Type

OBSERVATIONAL

Conditions

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

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

Min Age: 0 MonthsMax Age: 6 Months

Inclusion Criteria18

  • 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 Criteria3

  • Refusal to participate by the legal representative
  • Administration of palivizumab
  • Maternal vaccination against RSV.

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Interventions

BIOLOGICALa 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

Locations(3)

CHI Créteil

Créteil, France

CHU Necker

Paris, France

CHU Robert-Debré

Paris, France

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NCT07698769