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临床试验/NCT01046734
NCT01046734已完成不适用

Virus Shedding and Environmental Deposition of Novel A(H1N1) Pandemic Influenza Virus

University of Nottingham3 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
3
主要终点
Virus shedding and deposition as measured by virus culture and quantitative polymerase chain reaction (PCR).

研究概览

简要总结

An influenza pandemic has recently been declared, involving the novel A(H1N1) 'swine flu' virus. This has spread to almost 100 countries worldwide in less than two months, causing widespread disease so far in Mexico, USA and Canada. It is highly likely that over the next 12 months, many countries including the UK will be affected by widespread illness. In the UK this wave of intense flu activity is most likely to occur in late autumn 2009.

Very little is known about the new H1N1 pandemic virus. For example we do not know how long the virus is excreted by infected humans and how much virus is spread to surfaces and carried in the air. This is very important to know as soon as possible because it affects the advice that will be given to healthcare workers about controlling the spread of infection to themselves and other patients. Similarly we need this information so we can give good quality advice to families who will have to look after each other in their own homes.

The best way to obtain this information is to ask patients who get pandemic flu soon (in August, September and October) to help us by agreeing to give a daily nose swab sample for just over one week so we can see how much virus is in the nose day by day and how quickly this disappears. At the same time we will take samples from hard surfaces in a patient's room or home and sample the air using a special filter device. We can then work out how much virus is being excreted, how long the 'danger period' is, whether surfaces are more or less important than the air that we breathe (in terms of catching the virus) and if we can advise on a 'safe distance' from the patient, beyond which there is relatively little chance of catching the illness.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Month 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject fulfils case definition
  • Informed consent obtained (from Parent/Guardian where appropriate)
  • Age >1 month
  • Near-patient test positive for influenza A or other substantive test positive for influenza A (including 'swine flu')
  • Willing to participate and agrees to allow both nasal and environmental samples to be taken

排除标准

  • Illness for >48h (community cases)
  • Illness for >96h (hospital cases)
  • Existing case of ILI in the household
  • A negative for swine flu (as part of NHS care)
  • Has taken part in influenza research involving an investigational medicinal product within the last 3 months

结局指标

主要结局

Virus shedding and deposition as measured by virus culture and quantitative polymerase chain reaction (PCR).

时间窗: 6 months

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 (3)

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