NCT03025516Unknown不适用
Performance Evaluation of Two Diagnostic Technologies for TB Detection Based Upon Breath Testing
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Find
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Microbiological TB Diagnosis
研究概览
简要总结
This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy of two TB breath-based technologies independently of the manufacturers. Assay error and failure rates and device operational characteristics will also be assessed during this study. Participants will be enrolled in this study in line with FIND sample banking activities. Results from index tests will not be used to make clinical decisions. Participation in this study will not alter the standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms suggesting pulmonary TB, i.e. persistent cough (generally > 3 weeks or as per local definition of TB suspect) and at least one other finding listed below:
- •Persistent cough
- •Recent weight loss
- •Night sweats
- •Contact w/ active case
- •Loss of appetite
- •Other [specify]
- •Provision of informed consent to sample collection, banking and HIV and breath-based assay testing
- •Production of adequate quantity of sputum (sputum induction whenever possible)
- •Adult age (>18 years old)
排除标准
- •Participants receiving any anti-tuberculosis medication, including fluoroquinolone and aminoglycosides in the 60 days prior to enrolment.
- •Participants with ONLY extra-pulmonary disease will be excluded.
- •Participants for whom complete follow-up and a clear final diagnosis are judged to be difficult (e.g. residents elsewhere or about to move).
结局指标
主要结局
Microbiological TB Diagnosis
时间窗: 8 weeks
TB diagnosed by AFB smear microscopy or by one of two MGIT (liquid) or LJ (solid) cultures on enrollment or follow-up sputum sample
次要结局
未报告次要终点
研究者
研究点 (1)
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