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ENVIEANCILLAIRE: Efficacy of Nirsevimab in Children Hospitalised With RSV Bronchiolitis - A Subsidiary Study on the Immune Signature and Microbial Environment (ENVIEANCILLAIR)

2026年7月7日 更新者：Centre Hospitalier Intercommunal Creteil

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

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

110

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Créteil、法国
        • 招聘中
        • Chi Creteil
        • 接触：
          • Mickaël SHUM
      • Paris、法国
        • 招聘中
        • CHU Robert-Debré
        • 接触：
          • Naïm OULDALI, phD
      • Paris、法国
        • 招聘中
        • CHU Necker
        • 接触：
          • Julie TOUBIANA, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Case
Children aged 6 months or under included in the ENVIE study, treated for bronchiolitis caused by RSV
生物：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
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:

  • 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
  • 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
  • Treated for an acute surgical condition, 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.
生物：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

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Mucosal cytokine profile of patients (type I and III interferons, pro-inflammatory cytokines)
大体时间：Baseline
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Hospitalier Intercommunal Creteil

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年12月5日

初级完成 (估计的)

2026年12月5日

研究完成 (估计的)

2026年12月5日

研究注册日期

首次提交

2026年7月7日

首先提交符合 QC 标准的

2026年7月7日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年7月13日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2024-A01208-39

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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