Xpert MTB/RIF Test as the Initial Diagnostic Test in the Diagnosis of Pulmonary Tuberculosis: a Pragmatic Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 6,900
- 试验地点
- 8
- 主要终点
- diagnostic turnaround time
研究概览
简要总结
Currently in Taiwan, most clinicians use sputum smear and culture for the diagnosis of pulmonary tuberculosis (TB) and apply nucleic acid amplification (NAA) test in a selected manner. In 2013, the World Health Organization issued conditional recommendation that Xpert MTB/RIF may be used rather than conventional microscopy and culture as the initial diagnostic test in all adults suspected of having TB. The newly published Taiwan guidelines for TB diagnosis and treatment has recommended NAA test, together with smear and culture, as the initial diagnostic test in individuals suspected of having TB. The investigators conduct a prospective study to investigate the use of Xpert MTB/RIF as the initial diagnostic test of pulmonary TB under a pragmatic trial design.
详细描述
In this study the investigators will respect current practice in the use of NAA in the diagnosis of pulmonary TB. Clinicians may have ordered NAA as the initial diagnostic test in adults suspected of having pulmonary TB (group A, Immediate NAA by clinician), and the investigators will not intervene. For patients who do not have NAA as the initial diagnostic test, the investigators will use random permuted blocks to randomize these participants into two groups. One group will have immediate Xpert test (intervention group) as the initial diagnostic test and another group will continue usual care without immediate Xpert test (control group).
Group A (Immediate NAA by clinician): NAA as the initial diagnostic test for pulmonary TB requested by clinicians.
Group B (Immediate NAA as intervention): NAA as the initial diagnostic test for pulmonary TB not requested by clinicians, but is performed as intervention in this study (intervention group).
Group C (No immediate NAA): NAA as the initial diagnostic test for pulmonary TB not requested by clinicians, and is not performed as the initial diagnostic test in this study (control group). NAA may be ordered at a later point in time by clinicians as an add-on test after sputum smear microscopy.
The investigators will assess pulmonary TB cases detected in all groups regarding
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
both care providers and participants will be informed of positive results of Xpert MTB/RIF test
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All presumptive tuberculosis cases who have sputum examinations for the diagnosis of pulmonary TB
排除标准
- •Tuberculosis cases who have been on treatment for 14 or more days who have sputum examinations for follow-up
结局指标
主要结局
diagnostic turnaround time
时间窗: through study completion, an average of 1 year
The interval between sputum examinations and initiation of ant-TB treatment
次要结局
- culture positive pulmonary TB(through study completion, an average of 1 year)
- change diagnosis(12 months after the initiation of anti-tuberculosis treatment)
- treatment outcomes(12 months after the initiation of anti-tuberculosis treatment)