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临床试验/NCT01074736
NCT01074736已完成不适用

Host Genetic Susceptibility to Avian Influenza A/H5N1 in Vietnam, Thailand, Indonesia and Singapore

South East Asia Infectious Disease Clinical Research Network1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1

研究概览

简要总结

The identification and characterization of susceptibility loci for H5N1 infection in humans could have profound implications. The detection of host genetic factors may shed light on key pathogenic interactions between H5N1 and human cells, assisting in identifying the viral characteristics determining pandemic potential. In addition, the identification and verification of susceptibility loci would be followed by functional studies which might point the way to new therapeutic and preventive options.

The objective of this study is to investigate if host genetic factors are associated with susceptibility to influenza H5N1 illness

详细描述

This is primarily an hypothesis screening exercise and while guesses based on biological plausibility are possible, a comprehensive analysis of genetic susceptibility can only be achieved by a whole genome approach. Therefore we will test for genetic linkage and association using a large number of Single Nucleotide Polymorphisms (SNPs) spanning the whole genome.

Principal Investigators have access to information on all surviving and deceased laboratory confirmed H5N1 cases. These cases will form the study base. The epidemiologist will attempt to make telephone contact with either the recovered patient or,if the patient died, the closest relative of the deceased patient. The proposed study will be explained and permission will be sought for the epidemiologist and a study nurse to visit the household to explain the study in greater detail, to offer an opportunity for questions and, if the subject agrees, to obtain informed consent for participation. If the epidemiologist has difficulty in making contact with the case or their family the local public authorities will be asked to assist in making contact. Eligible family members of H5N1 cases will be identified by face-to-face interviews with the surviving confirmed cases or close family members of deceased cases.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • The individual had a clinically compatible illness (defined as respiratory symptoms and an abnormal chest x-ray or encephalitis), AND
  • Influenza A/H5 RNA identified in a clinical sample by reverse transcription-polymerase chain reaction [RT-PCR], OR
  • Influenza A/H5 cultured from a clinical sample, OR
  • High titres (1:80 or higher) of anti-H5 antibodies by microneutralization in convalescent samples of patients who had a compatible illness but no or negative RT-PCR, AND
  • The patient survived or if they died an archived biological specimen is available for potential DNA extraction, AND
  • Valid, written consent is obtained.
  • The biological parents and biological siblings of all the cases and any other family members linking two cases, AND
  • Valid, written consent is obtained.

排除标准

  • 未提供

研究者

发起方
South East Asia Infectious Disease Clinical Research Network
申办方类型
Network

研究点 (1)

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