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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
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). This sample collection will be carried out specifically for the study of immunity. Innate immune mediators (type I, II and III IFNs) and key inflammatory molecules (IL-6, TNF-alpha, IL-10) will be quantified, and adaptive immunity will be analysed by measuring local immunoglobulin titres (IgG, A, M, subclasses and specific antibodies against the inactivated virus) from the nasopharyngeal swab and blood samples absorbed onto filter paper. A blood sample may also be offered to 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 (identification of the host's protein, cellular and transcriptomic response). Finally, the bacterial microbiome (16S RNA) and the soluble virome will be characterised by high-throughput sequencing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Children aged 6 months or under included in the ENVIE study, treated for bronchiolitis caused by RSV |
| |
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a study of the mucosal immune signature associated with hospitalised RSV bronchiolitis | Biological | 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 :
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| Measure | Description | Time Frame |
|---|---|---|
| Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines) | Baseline |
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Inclusion Criteria:
Cases:
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:
Exclusion Criteria:
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Among children aged 6 months or younger included in the ENVIE study, the ENVIE_ancillaire study will be offered to those with RSV infection or to the control group.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie TOUBIANA, PhD | Contact | 01 44 49 57 44 | julie.toubiana@aphp.fr | |
| Camille JUNG, PhD | Contact | 0157022268 | camille.jung@chicreteil.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Créteil | Recruiting | Créteil | France |
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A nasopharyngeal swab using a FLOQ-SWAB™ swab and a fingertip blood sample on special blotting paper (dextro type).
It will be possible to request an additional sample as part of an advanced immunological study for infants weighing ≥ 5 kg. This sample comprises:
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| CHU Necker | Recruiting | Paris | France |
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| CHU Robert-Debré | Recruiting | Paris | France |
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