Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in HIV-Infected and HIV-Uninfected Pulmonary Tuberculosis Suspects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cepheid
- 入组人数
- 992
- 试验地点
- 1
- 主要终点
- Proportion of all participants with Xpert MTB/RIF Assay MTB positive in sputum #1 who are AFB smear positive and MGIT culture positive for M.tuberculosis.
研究概览
简要总结
This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a longitudinal study of pulmonary TB suspects who are undergoing sputum evaluation for pulmonary TB. The sensitivity and specificity of the Xpert MTB/RIF (Mycobacterium tuberculosis/rifampin) assay performed on the first sputum collected for Xpert testing will be compared to gold standard conventional culture methods on two sputum specimens, in HIV-infected and HIV-uninfected participants.
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
- 否
入选标准
- •Suspected pulmonary TB (more information on the criterion can be found in the protocol)
- •Men and women age equal to or greater than 18 years
- •Ability and willingness of candidate or legal guardian/representative to provide informed consent
- •Collection of two sputum samples for AFB smear and culture collected within 7 days prior to entry.
- •Availability of two samples for Xpert MTB/RIF testing collected within 7 days prior to entry.
- •Determination and/or documentation of HIV status
- •For HIV-positive candidates, a CD4+ cell count obtained within 45 days prior to study entry or drawn at the time of entry at any laboratory that has a CLIA certification or its equivalent.
排除标准
- •Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing
- •Receipt of more than 7 cumulative days of antibiotics intended for bacterial treatment that may have anti-tuberculosis activity, within the 14 days prior to first sputum collection
- •Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
结局指标
主要结局
Proportion of all participants with Xpert MTB/RIF Assay MTB positive in sputum #1 who are AFB smear positive and MGIT culture positive for M.tuberculosis.
时间窗: Week 0
Proportion of all participants with Xpert MTB/RIF Assay MTB positive in sputum #1 who are AFB smear negative and MGIT culture positive for M.tuberculosis.
时间窗: Week 0
Proportion of US participants with Xpert MTB/RIF Assay MTB negative in sputum #1 who are MGIT culture negative for M.tuberculosis.
时间窗: Week 0
次要结局
未报告次要终点