跳至主要内容
临床试验/NCT06017310
NCT06017310招募中不适用

Evaluation of the Type 1 IFN Response in Viral Infections

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Presence or Absence of a replicative virus detected by viral culture

研究概览

简要总结

Respiratory viral infections (RVIs) represent a major public health problem and a great burden in terms of morbidity and mortality in children and adults worldwide. To ascertain the source of an infection, microbiology laboratories routinely perform a crucial step: the search for the pathogen through Polymerase Chain Reaction (PCR). Due to the extensive variety of pathogens, testing for the existence of all potential viruses, bacteria, or fungi accountable for the infection is an impractical and time-intensive endeavor. Furthermore, the rise of novel pathogens, exemplified by those accountable for the recent SARS-CoV-2 pandemic, underscores the urgency of promptly developing new innovative diagnostic tests.

To address these needs, researchers have dedicated several years to developing indirect methodologies notably centered around utilizing markers derived from the host's immune system. Among these, one particularly promising approach focuses on measuring the expression of interferon-stimulated genes, which are uniquely triggered by viral infections, thereby facilitating viral diagnosis. This methodology's efficacy has been proven in the context of SARS-CoV-2 infections.

This study's objective is to assess the functionality of such a tool across a spectrum of Respiratory Viral Infections (RVIs) prevalent within a French population during the winter season.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Positive nasopharyngeal samples for the detection of a virus, for which the replicative character has been established by the viral culture technique (500µL minimum required)
  • Samples kept at the CRB since 2018
  • Information to patients carried out and non-objection collected-

排除标准

  • 未提供

结局指标

主要结局

Presence or Absence of a replicative virus detected by viral culture

时间窗: One sample at inclusion

RT-qPCR/qPCR-positive NPS will be inoculated on suitable cell lines using a culture medium appropriate for growth. Plates will be incubated at 33°C in 5% CO2 for 96 hours. Positive samples will be harvested for the confirmation technique, while negative samples will be cultured for 8 days. RNA or DNA from infected cells will be harvested and will be assayed with Panther Fusion® RT-PCR/PCR kits (Hologic Inc., San Diego, CA, USA) for viral identification, except for RSV and influenza A and B viruses (IAV/IBV) which were detected by immunofluorescence using Thermo ScientificTM IMAGENTM kits (Thermo Fischer Scientific, Waltham, MA, USA).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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