PACTR202203645724919招募中3 期
Safety, effectiveness, and feasibility of a short and all-oral treatment regimen for the treatment of rifampicin-resistant tuberculosis in Niger
DAMIEN FOUNDATIO0 个研究点目标入组 230 人开始时间: 2022年3月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6 Year(s) 至 12 Year(s)（—）
- 性别
- All
入选标准
- •1) have bacteriologically confirmed TB with evidence of resistance to rifampicin (for children the diagnosis is not always bacteriologically confirmed as the RR-TB diagnosis may be based on clinical TB diagnosis plus history of a close contact with a confirmed RR-TB case) and susceptibility to fluoroquinolones and
- •2) be willing and able to give informed consent to participate in the study (signed or witnessed consent if the patient is illiterate; signed or witnessed consent by a child's parent or legal guardian).
排除标准
- •1) previous treatment for more than one month with second-line TB drugs included in the to be evaluated treatment regimens,
- •2) a QTcF interval = 500 msec at baseline that is not corrected by medical management,
- •3) any other medical contraindications for taking the study regimens,
- •4) being younger than 6 years old, and
- •5) diabetes mellitus.
研究者
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