跳至主要内容
临床试验/NCT04412317
NCT04412317招募中不适用

National Observatory of the Care of Young Sick Children in Community or Not, Indications and Cost-effectiveness of PCR-Sars-CoV-2 - VIGIL Study

Centre Hospitalier Intercommunal Creteil2 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2020年6月3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
12,000
试验地点
2
主要终点
Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test

研究概览

简要总结

The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at a time when diagnostic testing for SARS-CoV-2 had to be performed according to specific clinical criteria (even if no clinical picture suggestive of COVID had been clearly identified). The management of sick young children (with respiratory tract infection that could be attributed to COVID) by pediatricians (infectious diseases specialists, emergency physicians, general practitioners, and outpatients) was facilitated by an algorithm whose objective was to help define the indications for SARS-CoV-2 PCR and subsequently for antigenic testing. The current technique of deep nasopharyngeal swabbing (for PCR or antigenic testing) is delicate and difficult in children, and is therefore a serious handicap for community-based screening, especially since infectious episodes are frequent in children. Since then, nasal self-tests that can be easily used in children have been commercialized and have facilitated screening.

Because of the similarity between the clinical signs of respiratory tract infections in children, it is often impossible to distinguish between different viral respiratory infections and epidemics may overlap in time. However, the identification of the pathogen is the key to improve management of these infectious diseases. The VIGIL study is therefore continuing, still facilitated by the existence of an active pediatric network existing for 20 years. ACTIV AFPA and GPIP have created networks of hospital and ambulatory pediatricians who actively participate in various observatories https://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatories have resulted in the publication of more than 80 articles in international journals (https://www.activ-france.com/fr/publications).

研究设计

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

入排标准

年龄范围
— 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children under 15 years of age
  • Prescription of a PCR-Sars-CoV-2
  • VIGIL information note given to parents

排除标准

  • Refusal to participate by the patient, family member or legal representative (depending on the situation)

结局指标

主要结局

Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test

时间窗: At inclusion

Number of positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test on total number of PCR

次要结局

  • Number of symptomatic children(the day of PCR or RAD result)
  • presence or absence of positive people in close contacts(the day of PCR or RAD result)
  • Percentage of RAD RSV and Flu positive in children with respiratory tract infection(the day of PCR or RAD result)
  • Accuracy of antigen test compared to PCR(the day of PCR or RAD result)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Use of PCR-Sars-CoV-2 in Children | 临床试验