结核病网络诊断快速研究 (R2D2TB Network)
结核病网络(R2D2 TB 网络)研究的诊断开发快速研究
研究概览
地位
条件
详细说明
结核病网络诊断开发快速研究(R2D2 结核病网络)研究旨在确定并严格评估在进行的临床研究中有前途的早期结核病(TB)分类、诊断和耐药性测试(以下简称“新测试”)预期用途的设置。 快速诊断、耐药性鉴定和有效治疗对于改善患者预后和减少结核病传播至关重要。 然而,护理级联分析和患病率调查表明,40-60% 的结核病患者并未开始接受有效治疗。 1,2 以目标产品概况 (TPP) 的形式描述了减少这种“诊断差距”所需的不同类型的测试。 优先级最高的 TPP 用于:1) 即时、非痰液生物标志物检测,以使用易于获取的样本(基于生物标志物的诊断检测)促进结核病快速诊断,以及 2) 简单、低成本一线卫生工作者可以用来排除结核病的测试(分类测试)。 R2D2 TB Network 研究将根据参考标准评估新型分类和诊断测试的敏感性和特异性,包括痰液/尿液 Gene Xpert® MTB/RIF(结核分枝杆菌/利福平)Ultra 和痰液分枝杆菌培养。 快速药敏试验 (rDST) 的敏感性和特异性将与参考标准进行比较,包括基于培养的表型 DST 和分枝杆菌 DNA 的全基因组测序 (WGS)。 此外,将通过对常规卫生工作者的直接观察和调查来评估新测试的可用性。
研究人员目前计划评估的新型结核分流、诊断和耐药性测试如表 1 所示。 将评估每个新测试的国家/研究地点如表 2 所示。 该主研究方案将进行更新,以包括已确定的其他新测试,或在完成评估后删除新测试。 其他原型 TB 分类、诊断和耐药性测试,包括与 TB 并行处理多种病原体的检测,将在随后的项目年中进行评估。
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Adithya Cattamanchi, MD
- 电话号码:+1-415-206-5489
- 邮箱:adithya.cattamanchi@ucsf.edu
研究联系人备份
- 姓名:Catherine Cook, MPH
- 电话号码:603-988-9940
- 邮箱:catherine.cook@ucsf.edu
学习地点
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Kampala、乌干达
- 招聘中
- Kisenyi Health Center
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接触:
- William Worodria
- 邮箱:worodria@yahoo.com
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Kampala、乌干达
- 招聘中
- Mulago Outpatient Department
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接触:
- William Worodria
- 邮箱:worodria@yahoo.com
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Tbilisi、乔治亚州
- 招聘中
- National Center for Tuberculosis and Lung Diseases
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接触:
- Nestani Tukvadze
- 邮箱:Nestan Tukvadze <marikushane@yahoo.com>
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Cape Town、南非
- 招聘中
- Brooklyn Chest Hospital
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接触:
- Grant Theron
- 邮箱:gtheron@sun.ac.za
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Cape Town、南非
- 招聘中
- Khayelitsha District Health Center
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接触:
- Grant Theron
- 邮箱:gtheron@sun.ac.za
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Cape Town、南非
- 招聘中
- Scottsdene primary care clinic
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接触:
- Grant Theron
- 邮箱:gtheron@sun.ac.za
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Cape Town、南非
- 招聘中
- Wallacedene primary care clinic
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接触:
- Grant Theron
- 邮箱:gtheron@sun.ac.za
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Cape Town、南非
- 招聘中
- Kraaifontein Community Health Clinic
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接触:
- Grant Theron
- 邮箱:gtheron@sun.ac.za
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Vellore、印度
- 招聘中
- Chitoor (Christian Medical College satellite campus)
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接触:
- DJ Christopher
- 邮箱:djchris@cmcvellore.ac.in
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Vellore、印度
- 招聘中
- Christian Medical College CMC Pulmonary Outpatient Department
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接触:
- DJ Christopher
- 邮箱:djchris@cmcvellore.ac.in
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Vellore、印度
- 招聘中
- Primary care clinics (Shalom/LCC, CHAD)
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接触:
- DJ Christopher
- 邮箱:djchris@cmcvellore.ac.in
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Dasmariñas、菲律宾
- 招聘中
- De La Salle Medical and Health Sciences Institute
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接触:
- Charles Yu
- 邮箱:chrlsyu@yahoo.com
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Hanoi、越南
- 招聘中
- Hanoi Lung Hospital, Outpatient departments
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接触:
- Nhung Nguyen
- 邮箱:vietnhung@yahoo.com
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Hanoi、越南
- 招聘中
- National Lung Hospital, Outpatient departments
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接触:
- Nhung Nguyen
- 邮箱:vietnhung@yahoo.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 对于结核病分诊/诊断测试的评估:我们将包括咳嗽持续时间≥2 周或已知结核病危险因素(HIV 或糖尿病)的成年门诊患者(年龄≥18 岁)。
- 对于 rDST 测试的评估:我们将包括根据常规诊断测试(通常基于 Xpert MTB/RIF、Xpert MTB/RIF Ultra 或 Hain MTBDRplus)对 TB 和 RIF 耐药呈阳性的成年人(年龄≥18 岁)。
- 对于可用性评估:我们将包括每个临床站点的卫生工作者,他们 1) 年龄≥18 岁和 2) 参与常规结核病检测(为结核病检测收集标本或执行结核病检测)。
排除标准:
- 对于结核病分诊/诊断测试的评估:我们将排除以下患者: 在过去 12 个月内完成潜伏性或活动性结核病治疗(分别增加结核病流行率和减少假阳性结果);在进入研究后 2 周内因任何原因服用过任何具有抗分枝杆菌活性的药物(包括氟喹诺酮类药物)(以减少假阴性);居住地距离研究地点 >20 公里或不愿返回进行后续访问;或不愿提供知情同意
- 对于 rDST 测试的评估:我们将排除以下患者: 所有基线(即入组)痰培养结果均为阴性或污染;无法在入组后的一天内提供至少两份 3 mL 的痰标本;或不能或不愿提供知情同意。
- 对于可用性评估:我们将排除不愿提供知情同意的员工。
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:评估各种新型结核病分类和诊断测试。
对于新型结核病分类和诊断测试,研究人员将对一群疑似患有结核病的成年人进行设计锁定测试的大规模评估,并对早期和晚期原型测试进行嵌套可行性/试点研究。
研究人员的目标是每年在五个招募点各招募 300-450 名参与者,以评估各种新型结核病分类和诊断测试,并招募 50 名卫生工作者来评估测试的可用性。
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我们将评估旨在使培养更灵敏、更快速且污染更少的测试。
我们将评估新的染色技术或可视化方法,以提高涂片显微镜的灵敏度。
我们将评估用于近护理点或护理点的半自动或自动化分子测定。
我们将评估用于近护理点或护理点的半自动或自动化分子测定。
我们将结合分析物浓度、更高灵敏度或特异性抗体或增强可视化等技术来评估尿液 LAM 检测,以改进 LAM 检测。
我们将评估旨在用于近护理点或护理点的宿主免疫反应参数的测定方法。
我们将评估评估挥发性有机化合物或呼出气冷凝物的检测方法,以用于近点护理或护理点检测结核病。
我们将评估基于人工智能的算法,评估图像(胸部 X 光、超声)或声音(咳嗽声、肺音),包括次声到超声电子听诊器(Level 42 AI,美国)。
我们将评估使用噬菌体裂解分枝杆菌细胞以检测 DNA 或抗原的检测方法。
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实验性的:新型 rDST 检测方法的评估
将要求参与地点的临床医生转诊通过常规分子检测发现利福平耐药的成年患者。
研究人员的目标是每年在三个招募点各招募 100-200 名患者,以评估新型 rDST 检测方法。
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我们将评估用于近护理点或护理点的半自动或自动化分子测定。
我们将评估靶向和全基因组测序测定。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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灵敏度
大体时间:2年
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使用微生物参考标准的结核病患者中给定指标测试的阳性结果数/(给定指标测试的总阳性 + 阴性结果)
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2年
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特异性
大体时间:2年
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使用微生物参考标准的非结核病患者中给定指标测试的阴性结果数/(给定指标测试的总阳性+阴性结果)
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2年
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合作者和调查者
合作者
调查人员
- 首席研究员:Adithya Cattamanchi, MD、University of California, San Francisco
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.