ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment
Recruiting now
Conditions studied: Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)
In brief
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
Key facts
- Study ID
- NCT07698769
- Run by
- Centre Hospitalier Intercommunal Creteil
- People needed
- 110
- Starts
- 2024-12-05
- Expected to finish
- 2026-12-05
- Last updated by the study team
- 2026-07-13
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Refusal to participate by the legal representative
- Administration of palivizumab
- Maternal vaccination against RSV.
Where it is running
- CHI Créteil — Créteil, France (enrolling)
- CHU Necker — Paris, France (enrolling)
- CHU Robert-Debré — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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