Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens Through Improved Epidemiologic Methods
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 3
- 主要终点
- End-of-treatment outcome
研究概览
简要总结
This is a multisite prospective cohort study of patients with multidrug- or rifampin-resistant tuberculosis who are treated with an all-oral shortened regimen under routine program conditions in one of three countries (Peru, Lesotho, Kazakhstan).
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
- 0 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions, per local country guidance, will be included.
排除标准
- •Exclusions are based on local guidance in each country. Currently, individuals with fluoroquinolone resistant tuberculosis are excluded from all-oral shortened treatment.
研究组 & 干预措施
Kazakhstan Cohort
550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions.
干预措施: Bdq, Lzd, Lfx, Z, Dlm (9-12 months) (Drug)
Lesotho Cohort
200 patients receiving an all-oral shorter regimen in Lesotho under routine program conditions.
干预措施: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months) (Drug)
Peru Cohort
50 patients receiving an all-oral shorter regimen in Peru under routine program conditions.
干预措施: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months) (Drug)
Kazakhstan Cohort
550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions.
干预措施: Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months) (Drug)
Kazakhstan Cohort
550 patients receiving an all-oral shorter regimen in Kazakhstan under routine program conditions.
干预措施: Bdq, Lzd, Lfx, Cfz, Cs (9-12 months) (Drug)
结局指标
主要结局
End-of-treatment outcome
时间窗: 9-12 months after treatment initiation
Number of individuals experiencing each tuberculosis treatment outcome (cure, completion, death, failure, lost-to-follow-up), assessed at the end of treatment by a clinician, based on culture results
Final tuberculosis treatment outcome
时间窗: 6-24 months after treatment completion
Number of individuals experiencing each final tuberculosis treatment outcome (cure, completion, death, failure, lost-to-follow-up, relapse), assessed at 6, 12, and 24 months by a clinician, based on culture results
Adverse events of interest
时间窗: Tuberculosis treatment, an average of 9 months
Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings
次要结局
未报告次要终点
研究者
Molly Franke
Associate Professor of Global Health and Social Medicine
Harvard Medical School (HMS and HSDM)