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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

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

Sex: All
Ages: 0 Months – 6 Months
Enrollment: 110
Sponsor: Centre Hospitalier Intercommunal Creteil

Location: CHI Créteil Créteil

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 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07698769). StuddyBuddy aggregates publicly available trial information.