NCT00767975已完成3 期
Active Screening of Latent TB Infection, Treatment and Long Term Follow-up in Prison
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,384
- 试验地点
- 1
- 主要终点
- COMPLETE RATE OF LTBI TREATMENT
研究概览
简要总结
LTBI Treatment is effective in prison
详细描述
LTBI treatment will be conducted in a prison with either isoniazid or rifampin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •all people who is LTBI, and have ability to sign the informed concent
排除标准
- •previously adverse effect from anti-TB medication complete treatment of TB in the pass; active TB AST, ALT > 3 times of normal limit platelet < 150 k/mm3 T-bil > 2 times of normal limit
研究组 & 干预措施
1
Experimental
Provided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness
干预措施: isoniazid , randomized, open label (Drug)
1
Experimental
Provided INH 6m or RMP 4 m; whether enter treatment arm is determined by patient's willingness
干预措施: rifampin, randomized, open label (Drug)
结局指标
主要结局
COMPLETE RATE OF LTBI TREATMENT
时间窗: 1.5 year
次要结局
- Efficacy(3 year)
研究者
研究点 (1)
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