ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment (ENVIEANCILLAIR)
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Julie TOUBIANA, PhD
- Telefonnummer: 01 44 49 57 44
- E-post: julie.toubiana@aphp.fr
Studer Kontakt Backup
- Navn: Camille JUNG, PhD
- Telefonnummer: 0157022268
- E-post: camille.jung@chicreteil.fr
Studiesteder
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-
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Créteil, Frankrike
- Rekruttering
- Chi Creteil
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Ta kontakt med:
- Mickaël SHUM
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Paris, Frankrike
- Rekruttering
- CHU Robert-Debré
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Ta kontakt med:
- Naïm OULDALI, phD
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Paris, Frankrike
- Rekruttering
- CHU Necker
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Ta kontakt med:
- Julie TOUBIANA, PhD
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Case
Children aged 6 months or under included in the ENVIE study, treated for bronchiolitis caused by RSV
|
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:
il sera possible de proposer un prélèvement supplémentaire dans le cadre d'une étude immunologique avancée, chez les nourrissons ≥ 5 kg. Ce prélèvement comprend :
|
|
Control group
Children aged 6 months or under included in the ENVIE study, admitted to a standard ward or a Short-Stay Unit, or who have attended the paediatric A&E department For one of the following reasons:
|
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:
il sera possible de proposer un prélèvement supplémentaire dans le cadre d'une étude immunologique avancée, chez les nourrissons ≥ 5 kg. Ce prélèvement comprend :
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines)
Tidsramme: Baseline
|
Baseline
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2024-A01208-39
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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