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Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France (RS-viro IRA)

Every year in the fall and winter, numerous respiratory viruses (such as influenza viruses, SARS-CoV-2 (COVID-19), RSV, rhinovirus, and metapneumovirus) circulate in mainland France, causing acute respiratory infections (ARIs). These viruses can cause epidemics of varying severity, requiring close monitoring to determine their circulation levels and adapt public health measures accordingly. In France, ARI surveillance relies on two networks: the Sentinelles network in primary care and the RENAL network in hospitals. The Sentinelles surveillance is conducted in collaboration with Santé publique France, the National Reference Center for Respiratory Infection Viruses (Institut Pasteur and Hospices Civils de Lyon), and the University of Corsica. As part of the virological surveillance of ARIs, Sentinelles physicians are asked to collect nasopharyngeal swabs or saliva samples from a sample of patients presenting with an ARI during their clinic visits. This surveillance makes it possible to identify respiratory viruses circulating in primary care (general practice and pediatrics), to describe confirmed cases for each of the circulating viruses, and to estimate the impact of each on general practice. This surveillance also allows for the evaluation of the effectiveness of vaccines against influenza and COVID-19.

研究概览

研究类型

观察性的

注册 (估计的)

25000

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

      • Paris、法国
        • 招聘中
        • IPLESP - UMR S 1136, N° BC 2908, Faculté de médecine Sorbonne Université, site Saint Antoine, 27 rue Chaligny
        • 接触:
        • 首席研究员:
          • Thierry BLANCHON

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
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients seen in GPs' consultation with an acute respiratory infection

描述

Inclusion Criteria:

  • be seen by a general practitioner or pediatrician participating in the Sentinelles surveillance program;
  • between week 40 (late September-early October) and week 15 (mid-April) of each year
  • have an acute respiratory infection (ARI) as defined below: Sudden onset of fever (or feeling of fever) and respiratory symptoms
  • have given oral consent to participate in this monitoring or, in the case of minors, oral consent given by the child's legal guardian(s) present at the consultation

Exclusion Criteria:

  • a person who is subject to a court-ordered protective measure;
  • a person who is under guardianship or conservatorship, unless accompanied by their legal guardian or unless the legal guardian objects to their participation;
  • a person who is not in a condition to receive information or give consent.

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
Individuals with an ARI consulting a GP or a private pediatrician in mainland France

Based on the protocol, physicians perform either a nasopharyngeal swab or saliva collection on included patients. The method is determined by scientific data and epidemiological constraints, not by the patient.

Saliva collection:

The physician oversees the collection during the visit using the provided kit (pipette, tube, etc.).

Depending on constraints, the patient may perform the collection at home if agreed upon.

If the patient is unable to self-collect (e.g., infants, facial paralysis), the physician collects the saliva directly from under the tongue using the pipette.

Based on the protocol, physicians perform either a nasopharyngeal swab or saliva collection on included patients. The method is determined by scientific data and epidemiological constraints, not by the patient.

Nasopharyngeal sampling: During the consultation, the physician performs a deep nasal swab using the provided kit (FFP2 mask, swab, transport tube, absorbent, SafetyBag, and pre-paid envelope for partner labs).

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Proportion of acute respiratory infection (ARI) cases seen in private practice (general practice and pediatrics) that tested positive for influenza viruses (by type and subtype), SARS-CoV-2, RSV, rhinovirus, and metapneumovirus
大体时间:Baseline
Baseline

次要结果测量

结果测量
大体时间
Weekly incidence rate of acute respiratory infections caused by influenza viruses and SARS-CoV-2 seen in general practice
大体时间:Baseline
Baseline
Proportion of patients included vaccinated against influenza
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。

调查人员

  • 首席研究员:Thierry BLANCHON, MD, PhD、Institut National de la Santé Et de la Recherche Médicale, France

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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)

2026年5月14日

初级完成 (估计的)

2031年5月14日

研究完成 (估计的)

2031年5月14日

研究注册日期

首次提交

2026年5月6日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

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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