Comparison of treatment completion rates with three short-course rifamycin-based regimens (three months of daily isoniazid plus rifampicin [3HR], three months of once-weekly isoniazid plus rifapentine [3HP], and four months of daily rifampicin [4R]) for treatment of latent tuberculosis infection in patients with end-stage kidney disease: A randomised controlled clinical trial (RIFAKiD-TB Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 7
- 主要终点
- The primary endpoint will be the proportion of participants who complete the assigned treatment regimen, defined as: 1) 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than on 2 occasions, for the 3HR arm (control)
研究概览
简要总结
To determine if treatment completion with three months of once-weekly isoniazid plus rifapentine (3HP) or four months of daily rifampicin (4R) is better compared with three months of daily isoniazid plus rifampicin (3HR) for treatment of latent tuberculosis infection in patients with endstage kidney disease.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older with kidney disease stage ≥ 4 (glomerular filtrate rate ≤29 mL/minute or under substitutive renal therapy) who require treatment for latent tuberculosis infection.
- •Female with negative pregnancy test prior to enrolment.
- •Female of childbearing age willing to take appropriate barrier contraceptive measures.
- •Informed written consent.
排除标准
- •Prior allergy/intolerance to rifamycins or isoniazid.
- •Pregnancy or breastfeeding.
- •Pre-treatment transaminases (ALT and/or AST) >5-fold of the upper limit of the normality titer.
- •Concomitant treatment with drugs contraindicated with the study medications.
- •Having received rifamycins or isoniazid within the two previous weeks.
- •Weigh <32 Kgs.
- •Inability to understand the nature of the study or to give written consent.
结局指标
主要结局
The primary endpoint will be the proportion of participants who complete the assigned treatment regimen, defined as: 1) 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than on 2 occasions, for the 3HR arm (control)
The primary endpoint will be the proportion of participants who complete the assigned treatment regimen, defined as: 1) 90 doses within a maximum of 16 weeks, without interruptions longer than 2 weeks, and no more than on 2 occasions, for the 3HR arm (control)
2) 12 doses within a maximum of 14 weeks, without interruptions longer than 10 days, for the 3HP arm (experimental 1)
2) 12 doses within a maximum of 14 weeks, without interruptions longer than 10 days, for the 3HP arm (experimental 1)
3) 120 doses within a maximum of 20 weeks, without interruptions longer than 2 weeks, and no more than on two occasions, for the 4R arm (experimental 2).
3) 120 doses within a maximum of 20 weeks, without interruptions longer than 2 weeks, and no more than on two occasions, for the 4R arm (experimental 2).
次要结局
- 1. Proportion of participants who discontinue permanently the assigned treatment because of adverse events, regardless of its relationship to the treatment of the study 2. Proportion of participants.
- 2. Proportion of participants who discontinue permanently the assigned treatment because of adverse events, related to the treatment of the study.
- 3. Crude mortality: Number of participants who die while on the study.
研究者
Miguel Santin
Scientific
Bellvitge University Hospital