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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

Sponsor: Centre Hospitalier Intercommunal Creteil

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

0 Months - 6 Months

Study Type

OBSERVATIONAL

Enrollment

110

Start Date

2024-12-05

Completion Date

2026-12-05

Last Updated

2026-07-13

Healthy Volunteers

Not specified

Interventions

BIOLOGICAL

a 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