A Prospective, Randomized, Open Labeled Trial of Isoniazid Treatment Based on ELISPOT Assay to Prevent Tuberculosis in a Kidney Transplant Recipient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 831
- 试验地点
- 1
- 主要终点
- Development of tuberculosis (the rate of tuberculosis after transplantation)
研究概览
简要总结
It has been recommended that all transplant recipients undergo a tuberculin skin test (TST) before transplantation. However, the ability of TST to diagnose latent tuberculosis infection (LTBI) in transplant candidates has been reported to be suboptimal because of high rates of false-negative and false-positive results. The enzyme-linked immunospot assay (ELISPOT) detecting interferon-gamma secreting T-cells for diagnosing tuberculosis infection gave promising results in immunocompromised patients as well as in immunocompetent patients. The investigators will perform a randomized, open-label, prospective trial of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients.
详细描述
Our previous data have shown that ELISPOT assay was more sensitive to detect LTBI in renal transplant recipients than TST (Kim SH, et al. Transplant Infect Dis 2010 Jan 25 [Epub ahead of print]). However, further studies are eagerly awaited to determine the efficacy of isoniazid (INH) prophylaxis based on ELISPOT assay for LTBI in renal transplant recipients. All adult patients admitted for renal transplantation between May 2010 and April 2013 at the Asan Medical Center, Seoul, South Korea, will be prospectively enrolled. INH (300 mg/day for 9 months) prophylaxis group and no prophylaxis group (control group) will be randomly assigned to all patients with a baseline positive ELISPOT assay regardless of the results of TST. The investigators will compare cumulative probability of developing active TB after transplantation between INH prophylaxis group and control group as primary outcome. Secondary outcomes will be adverse drug reactions, rejection episodes, graft survival, and mortality.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 years or more
- •Kidney transplant recipients
排除标准
- •Patients who do not receive isoniazid treatment due to abnormal liver function (i.e. Child-Pugh Score B or C)
- •Patients who have clinical risk factors for latent tuberculosis infection
- •Close contact with a person with pulmonary TB within the past year
- •Abnormal chest radiography and no prior prophylaxis
- •A history of untreated or inadequately treated TB
- •New infection (i.e. a recent conversion of TST to positive status)
- •If kidney transplant donor has these clinical risk factors for latent tuberculosis infection, the transplant recipient from this donor will be excluded from this study.
研究组 & 干预措施
INH treatment group
- randomly allocated to INH treatment group in renal transplant recipients with ELISPOT (+)
- INH 300 mg po qd for 9 months
干预措施: Isoniazid treatment (Drug)
结局指标
主要结局
Development of tuberculosis (the rate of tuberculosis after transplantation)
时间窗: 3 years
Confirmed tuberculosis Probable tuberculosis Suspected or possible tuberculosis
次要结局
- All cause deaths(3 years)
- INH-associated adverse drug reactions(3 years)
- Graft failure(3 years)
研究者
Sung-Han Kim
Assistant Professor
Asan Medical Center