跳至主要内容
临床试验/NCT05827601
NCT05827601Enrolling By Invitation不适用

Active Surveillance of Influenza Virus Zoonotic Transmission Events: a Pilot Study in Belgium

Cyril Barbezange1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
1
主要终点
Number of sentinel participants positive for a non-seasonal influenza virus

研究概览

简要总结

The project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). Clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic surveillance of potential transmission of animal (avian or swine) influenza viruses to humans, only follow-up of people showing clinical symptoms. People working with potentially infected animals have the highest risk. Moreover, they can represent the first steps in a pandemic: if the virus adapts to humans, infected workers could potentially spread the virus to other people.

Currently, highly pathogenic clade2.3.4.4b H5 avian influenza viruses are continuously circulating in wild birds in Belgium and the number of introduction in poultry farms has raised, increasing the contact opportunities with high viral concentrations. Several reports of suspected human infection have been made by different countries. In addition, the virus was detected in sick non-human mammals. The large circulation in wild birds thus represents an increase risk of spill-over to mammalian species, including humans, (by contact directly with wild birds, or via outbreaks in poultry). This increased opportunity for accidental spillover to new host species increases the chances for the avian virus to adapt to mammals, including humans.

Likewise, there have also been an increased number of human cases of swine influenza reported by several European countries. A pro-active surveillance aiming at also detecting asymptomatic infections would allow an early detection of transmission that could help to prevent a new pandemic.

As a piloting approach during this specific project, some dedicated sentinel networks among at-risk workers will be initiated: people in poultry farms involved with the management of outbreaks of highly pathogenic avian influenza; people working at bird (or more generally wild life) rehabilitation centres or poultry farms; veterinarians working in pig farms/slaughterhouses.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • worker or volunteer of one of the targeted groups at one of the selected sites and accepting to take part in the study
  • to have regular contacts with animals within job/activity framework
  • being committed to take the regular samples

排除标准

  • people who had a broken nose might have difficulties to perform self-swabbing

结局指标

主要结局

Number of sentinel participants positive for a non-seasonal influenza virus

时间窗: every 2 weeks through study completion (December 2024)

result of RT-qPCR test to detect and characterize non-influenza viruses

Number of outbreak participants positive for a non-seasonal influenza virus

时间窗: every 2 days during 2 weeks after enrollment

result of RT-qPCR test to detect and characterize non-influenza viruses

次要结局

  • Number of outbreak participants with seroconversion against a non-seasonal influenza virus(at enrollment and about 4 weeks after)

研究者

发起方
Cyril Barbezange
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Cyril Barbezange

Head of Belgian National Influenza Centre

Sciensano

研究点 (1)

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