EUCTR2016-003567-20-DK进行中（未招募）1 期
A randomised controlled trial of a 12-dose rifapentine and isoniazid (RPT+INH) regimen using direct observed therapy (DOT) versus 6 months of daily isoniazid for latent tuberculosis infection (LTBI) in socially marginalised people
Dept of Infectious Diseases, Aarhus University Hospital0 个研究点目标入组 150 人开始时间: 2016年11月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Reporting to be homeless (independent of whether the person has an official address) or regularly seeking homeless shelters or public institutions to supply basic needs
- •LTBI defined by positive IGRA test
- •Found plausible by study doctor that the person has been exposed to tuberculosis within 2 years
- •Aged 18 years or older
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previously treated for tuberculosis
- •Pregnant or breastfeeding
- •Active tuberculosis (evaluated by chest x-ray and examination by a trained doctor)
- •Unable to give informed consent
- •Tested positive for LTBI as part of contact investigation where the index case has or is suspected to have INH of RIF resistant TB
- •Known HIV on antiretroviral treatment
- •Known allergy to rifamycins or isoniazid
- •Known epilepsy
- •Known liver disease causing affected liver parameters (ALAT, alkaline phosphatase, bilirubin, INR)
- •Any lab abnormality, disease, concomitant medication or condition that, in the opinion of the investigator, excludes a person from participating
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