Tuberculosis Sentinel Research Network (TB-SRN)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving successful pulmonary tuberculosis treatment outcome at the end of TB treatment
研究概览
简要总结
The overarching objective/aim of the study is to assess pulmonary TB treatment and longer-term outcomes among people with and without HIV in African population in order to inform policy and practice around TB treatment and create a platform for additional TB research in Zambia
详细描述
The TB-SRN study will be a prospective observational non-interventional study open to enrollment for individuals ≥15 years of age diagnosed with active pulmonary TB that is either bacteriologically confirmed or clinically diagnosed in HIV-positive and HIV-negative participants. The enrollment will be consecutively, regardless of drug resistance and HIV status. When the sample size of 300 consecutively enrolled TB patients is reached per site, we will enroll additionally drug-resistant TB patients (defined as GeneXpert MTB/RIF positive) until will reach a target of 150 drug resistant TB patients at each site. TB treatment will be managed according to and by the existing standard of care/systems, but those who provide informed consent and agree to participate will contribute other study-related data, which may require additional radiograph(s), laboratory tests, and healthcare-related outcomes measures beyond those collected during routine care. Participants may be co-enrolled in an affiliated or external observational or interventional study
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
- 15 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Be ≥15 years of age
- •Clinically diagnosed pulmonary TB and initiated/to be initiated on anti-TB treatment, as determined by medical providers through standard of care, on the basis of either.
- •Microbiologically confirmed pulmonary TB based on sputum or other respiratory samples with either
排除标准
- •Have plans to follow-up for TB care at a site distant from the enrollment site, imminent plans to move from his/her current area of residence, or plans to return to a distant area of residence, which would interfere with the participant's ability to complete all study visits (through the 12-month post-treatment visit).
- •1. Received >1 week of TB treatment within the prior 30 days, excluding TB preventive therapy
- •3. Have substantial cognitive impairment that in the opinion of the site investigator or designee may interfere with the ability to give reliable informed consent
结局指标
主要结局
Proportion of participants achieving successful pulmonary tuberculosis treatment outcome at the end of TB treatment
时间窗: 4 YEARS
The proportion of participants who achieve a successful pulmonary tuberculosis treatment outcome at the end of the TB treatment period. Treatment success will be defined according to the study-prespecified TB treatment outcome definitions and will be compared between participants with and without HIV.
次要结局
未报告次要终点