Design of an Integrative Algorithm for Staging Tuberculosis
赞助:
Fundació Institut Germans Trias i Pujol
合作者:
信息的提供 (责任方):
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追踪信息 | |||
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首次提交日期 ICMJE | September 3, 2017 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 2, 2018 | ||
预计研究开始日期 ICMJE | April 19, 2018 | ||
预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Clinical and microbiological changes[ Time Frame: timepoints 0 (at inclusion), at month 2 and month 6 (and month 12 if MDR/XDR) ] Changes in clinical status and microbiological cultures |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Design of an Integrative Algorithm for Staging Tuberculosis | ||
正式标题 ICMJE | Design of an Integrative Algorithm for Staging Tuberculosis to Improve Clinical Management. | ||
简要概况 | Tuberculosis is a chronic infectious disease that affects 10 million people, 300 in the city of Barcelona, every year. With serious consequences at public health level, it is associated with other diseases, and generated and influenced by many social and psychological factors. This study aims to stage tuberculosis disease by an integrative approach. |
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详细说明 | Tuberculosis is a chronic infectious disease that affects 10 million people, there are 300 new cases 300 in the city of Barcelona, every year. Tuberculosis has serious consequences at public health level. It is associated with other diseases, and generated and influenced by many social and psychological factors. This study aims to stage tuberculosis disease by a novel integrative approach. | ||
研究类型 ICMJE | Observational [Patient Registry] | ||
研究阶段 | |||
研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational [Patient Registry] 盲法描述: 主要目的: |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
200 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | February 2020 | ||
预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - TB diagnosis (all forms), microbiologically confirmed (by AFB+, GenXpert+ or Culture+) - Clinical management of the patients being done at Servicios Clínicos, Hospital Universitari Vall d'Hebron-Drassanes or Hospital Universitari Germans Trias i Pujol. Exclusion Criteria: - Not consenting to data/samples donation | ||
性别 |
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年龄 | 最小年龄:N/A ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Spain | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | , | ||
研究赞助商 ICMJE | Fundació Institut Germans Trias i Pujol | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | |||
验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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