宿主对甲型 H5N1 禽流感的遗传易感性
2010年11月3日 更新者：South East Asia Infectious Disease Clinical Research Network
越南、泰国、印度尼西亚和新加坡的宿主对禽流感 A/H5N1 的遗传易感性
人类 H5N1 感染易感位点的鉴定和表征可能具有深远的意义。 宿主遗传因素的检测可能会阐明 H5N1 与人类细胞之间的关键致病相互作用，有助于确定决定大流行潜力的病毒特征。 此外，易感位点的鉴定和验证之后将进行功能研究，这可能为新的治疗和预防选择指明方向。
本研究的目的是调查宿主遗传因素是否与 H5N1 流感疾病的易感性相关
研究概览
地位
完全的
详细说明
这主要是一个假设筛选练习，虽然基于生物学合理性的猜测是可能的，但遗传易感性的综合分析只能通过全基因组方法来实现。 因此，我们将使用跨越整个基因组的大量单核苷酸多态性 (SNP) 来测试遗传连锁和关联。
首席调查员可以获得所有幸存和死亡的实验室确诊 H5N1 病例的信息。 这些案例将构成研究基地。 流行病学家将尝试通过电话联系康复的患者，或者如果患者死亡，则与已故患者的最近亲属进行电话联系。 将对拟议的研究进行解释，并征求流行病学家和研究护士的许可，以访问家庭以更详细地解释研究，提供提问机会，如果受试者同意，则获得参与的知情同意。 如果流行病学家难以与病例或其家人联系，将要求当地公共部门协助联系。 符合条件的H5N1病例家属将通过与幸存确诊病例或已故病例近亲的面对面访谈确定。
研究类型
观察性的
注册 (实际的)
500
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Hanoi、越南
- Oxford University Clinical Research Unit
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
- 经实验室证实感染 H5N1 的有症状病例将有资格纳入。
- 将优先招募来自多病例家庭的病例，以最大限度地增加纳入具有遗传病因的病例的可能性。
描述
纳入标准：
- 该人患有临床上相容的疾病（定义为呼吸道症状和异常的胸部 X 光检查或脑炎），并且
- 通过逆转录-聚合酶链反应 [RT-PCR] 在临床样本中鉴定的流感 A/H5 RNA，或
- 从临床样本中培养的 A/H5 流感病毒，或
- 患有相容性疾病但没有 RT-PCR 或阴性的患者的恢复期样本通过微量中和产生高滴度（1:80 或更高）的抗 H5 抗体，以及
- 患者幸存或如果他们死亡，存档的生物标本可用于潜在的 DNA 提取，并且
- 获得有效的书面同意。
- 所有病例的亲生父母和亲生兄弟姐妹以及将两个病例联系起来的任何其他家庭成员，以及
- 获得有效的书面同意。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Tawee Chotpitayasunond, Professor、Queen Sirikit National Institute of Child Health, Bangkok, Thailand
- 首席研究员：Herawati Sudoyo, Dr.、Eijkman Institute for Molecular Biology
- 首席研究员：Tran Hien Nguyen, Professor、National Institute of Hygiene and Epidemiology, Hanoi, Vietnam
- 首席研究员：Martin Hibberd, Dr.、Genome Institute of Singapore, Singapore
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Katz JM, Lim W, Bridges CB, Rowe T, Hu-Primmer J, Lu X, Abernathy RA, Clarke M, Conn L, Kwong H, Lee M, Au G, Ho YY, Mak KH, Cox NJ, Fukuda K. Antibody response in individuals infected with avian influenza A (H5N1) viruses and detection of anti-H5 antibody among household and social contacts. J Infect Dis. 1999 Dec;180(6):1763-70. doi: 10.1086/315137.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年7月1日
初级完成 (实际的)
2010年8月1日
研究完成 (实际的)
2010年10月1日
研究注册日期
首次提交
2010年2月23日
首先提交符合 QC 标准的
2010年2月23日
首次发布 (估计)
2010年2月24日
研究记录更新
最后更新发布 (估计)
2010年11月4日
上次提交的符合 QC 标准的更新
2010年11月3日
最后验证
2010年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
甲型流感病毒/H5N1 亚型的临床试验
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Biomedical Advanced Research and Development AuthorityPPD完全的