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

Recruitingn/aAges 0 Months - 6 MonthsAllCentre Hospitalier Intercommunal Creteil
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

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

3 sites
CHI Créteil
Créteil, France
CHU Necker
Paris, France
CHU Robert-Debré
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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