NCT06512831已完成不适用
Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients: A Retrospective Cohort Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,348
- 试验地点
- 1
- 主要终点
- The incidence of post-transplant active TB
研究概览
简要总结
Tuberculosis (TB) is a major and severe opportunistic infection among solid organ transplant recipients. Chemoprophylaxis is advised for those with latent tuberculosis infection (LTBI). However, the effectiveness of an isoniazid (INH) prophylactic approach based on TB risk factors, without relying on tuberculin skin test (TST) or interferon-gamma release assay (IGRA), remains uncertain. Therefore, the investigators conducted this retrospective study to evaluate the safety and efficacy of a 6-month INH prophylaxis regimen guided by TB risk factors in kidney transplant recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •living-donor kidney transplant recipients
- •receiving standard triad immunosuppressive regimen
排除标准
- •active TB infection
- •multiorgan transplantation
- •liver cirrhosis
- •malignancy history in the donor and recipient
- •human immunodeficiency virus infection
- •those who had received a nine-month course of INH.
研究组 & 干预措施
TB Risk factors with INH group (R-INH)
Experimental
干预措施: Isoniazid (Drug)
结局指标
主要结局
The incidence of post-transplant active TB
时间窗: from transplant to post-transplant for up to 5 years
次要结局
- The incidence of side effects of INH(Within 6 months of INH regimen)
研究者
Tao Lin
Professor Tao Lin
West China Hospital
研究点 (1)
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