ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment
Recruiting
Observational Study
Mucosal Cytokine Profile of Patients (Type I and III Interferons, Pro-inflammatory Cytokines)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 0 Months – 6 Months
- Sex
- Any
- Study type
- Observational
- Participants needed
- 110 (estimated)
- Sponsor
- Centre Hospitalier Intercommunal Creteil · Other
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About This Trial
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 wh…
Trial Locations
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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
Cont…
Contacts