A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Negative culture conversion until 8 weeks after initiation of treatment
研究概览
简要总结
The objective of this study is to compare how accurately the Xpert MTB/RIF assay Ct value at diagnosis and the AI-based tuberculosis activity score predict the treatment outcome of rifampin-susceptible pulmonary tuberculosis patients. As a retrospective observational study, data from patients diagnosed with rifampin susceptible pulmonary tuberculosis through the Xpert MTB/RIF assay performed on sputum in 2019 at the participating institutions will be analyzed (up to 900 people).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with rifampin-susceptible pulmonary tuberculosis by Xpert MTB/RIF assay with sputum samples between January 1, 2019 and December 31, 2019
排除标准
- 未提供
结局指标
主要结局
Negative culture conversion until 8 weeks after initiation of treatment
时间窗: Within 8 weeks of initiating treatment
Conversion from positive tuberculosis culture to negative tuberculosis culture
Time to negative culture conversion
时间窗: Within 6 months of initiating treatment
Time (days) to conversion from positive tuberculosis culture to negative tuberculosis culture
Treatment outcome including 1) Cure 2) Treatment completion 3) Treatment failure 4) Death 5) Loss of follow-up 6) Unknown
时间窗: Within 2 years of initiating treatment
1. Cure: confirmed negative culture conversion plus negative culture results from at least one sputum on the month of treatment completion 2. Treatment completion: confirmed negative culture conversion at least once during treatment 3. Treatment failure: positive culture results after 4 months of treatment 4. Death: death during treatment 5. Loss of follow-up: loss of follow-up during treatment 6. Unknown
次要结局
未报告次要终点
研究者
Jae-Joon Yim
Principal Investigator
Seoul National University Hospital