Multicentre Clinical Trial to Assess the Performance of the Xpert MTB/XDR Assay for INH- and Second-line Resistance Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 710
- 试验地点
- 1
- 主要终点
- Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection
研究概览
简要总结
FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the development, evaluation and introduction of an Xpert MTB/XDR assay
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •• Age 18 years or above;
- •Symptoms suggesting pulmonary TB, i.e. persistent cough (generally ≥3 weeks or as per local definition of TB suspect), and at least one of the following:
- •Previously received >1 month of treatment for a prior TB episode or
- •Failing TB treatment with positive sputum smear or culture after ≥3 months of a standard TB treatment or
- •Had close contact with a known drug-resistant TB case or
- •Newly diagnosed with MDR-TB within the last 30 days or
- •Previously diagnosed with MDR-TB and failed TB treatment with positive sputum smear or culture after ≥3 months of a standard MDR-TB treatment regimen
- •Patients meeting the above criteria will be screened by Xpert MTB/RIF or Xpert MTB/RIF Ultra. TB patients meeting the following criteria will be included in the study:
- •A clear Mtb-positive and RIF-resistant or RIF-sensitive result by Xpert MTB/RIF or Xpert MTB/RIF Ultra
- •Provision of informed consent;
- •Production of an adequate quantity (>3mL) of sputum
排除标准
- •Participants will be excluded from the study if informed consent is not provided.
结局指标
主要结局
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for INH and ETH resistance detection
时间窗: Day 1
Sensitivity and specificity estimates for INH and ETH resistance detection
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for fluoroquinolone resistance detection
时间窗: Day 1
Sensitivity and specificity estimates for fluoroquinolone resistance detection
Estimate the diagnostic accuracy of the Xpert MTB/XDR assay for second-line injectable resistance detection
时间窗: Day 1
Sensitivity and specificity estimates for second-line injectable resistance detection
次要结局
未报告次要终点