Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Kidney Transplant Recipients (ACE-KT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- CMV infection
研究概览
简要总结
CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before solid organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of CMV development after solid organ transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in kidney transplant candidates to predict the development of CMV infection after kidney transplantation.
详细描述
Between Mar 2014 and Mar 2015, all patients admitted in the kidney transplant unit will be enrolled in this study. All patients will receive CMV-specific ELISPOT assay and be prospectively followed for the development of CMV infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 16 or more
- •agree with written informed consent
排除标准
- •donor CMV IgG (+) and recipient CMV IgG (-)
结局指标
主要结局
CMV infection
时间窗: 6 months after transplantation
CMV infection is defined as follows. 1. CMV viremia: CMV antigenemia or CMV quantitative PCR (+) 2. CMV disease: CMV syndrome or tissue-invasive CMV disease i) CMV syndrome: ① CMV viremia ② temperature \> 38 without other cause ③ WBC \< 4000, atypical lymphocyte \> 3%, transaminase elevation, platelet \< 100,000/mm ii) tissue-invasive CMV disease: evidence of CMV in histopathologic specimen (inclusion body or viral antigen in biopsy or bronchoalveolar lavage fluid)
次要结局
- rejection(6 months after transplantation)
- graft loss(6 months after transplantation)
- mortality(6 months after transplantation)
研究者
Sung-Han Kim
Associate Professor
Asan Medical Center