ACTRN12622000115730尚未招募4 期
Test and Treat to End Tuberculosis (TB): Investigating the effect of a screening for, and treatment of, latent TB infection (LTBI) in the general population on the prevalence of TB in that population.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 208,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 5 Years 至 o limit（—）
- 性别
- All
入选标准
- •Eligibility criteria for TEST phase
- •1.Aged 5 years or older on the date of enumeration; AND
- •2.Capable of giving informed consent or, if aged < 15 years, having a parent or guardian who can give consent. Assent will also be routinely sought from children aged 10 to <15 years; AND
- •3.Not currently taking treatment for tuberculosis.
- •Eligibility criteria for TREAT phase
- •1.Meet eligibility criteria for testing and consented to screening; AND
- •2.Tuberculin skin test (TST) reaction size >= 10mm (or > 0mm if known to be HIV +ve) AND
- •3.Either no abnormality consistent with TB on chest radiograph OR abnormal radiograph but two sputum specimens are culture negative for M. tuberculosis
排除标准
- •1. Pregnant or planning to be pregnant in next 6 months
- •2. Important potential drug interactions with the intervention regimen, defined by attending medical officer in accordance with a schedule.
- •3. Known allergy or hypersensitivity to the active substance or any of the ingredients of the study drugs
- •4. Has completed a course of treatment for TB within the preceding two years.
- •5. Serum transaminases (AST and ALT) are both >= 3 x upper limit of normal
- •6. Severe or life-threatening illness that is considered by the attending medical officer to make treatment for LTBI inappropriate.
研究者
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