EVITA Study - Epstein-Barr Virus Infection moniToring in renAl Transplant Recipients - Early Identification of Increased Risk of Infection and Cancer for Individualised Immunosuppression.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 509
- 试验地点
- 3
- 主要终点
- The incidence rate of EBV driven PTLD
研究概览
简要总结
Transplant recipients are treated with immunosuppressive drugs to avoid rejection of the transplanted organ. As the medication impairs the immune response, it also increases the risk of serious infections and cancer in transplant recipients compared with the general population.
Previous studies have shown a close association between Epstein-Barr virus (EBV) and post transplant lymphoproliferative disorder (PTLD), with frequent demonstration of the virus in lesional tissues. Transplant recipients without evidence of EBV infection prior to transplantation (EBV seronegative) are at particularly high risk of developing PTLD. Other risk factors include a high viral load. As part of a preventive approach against PTLD, several transplantation units now monitor the occurrence of EBV DNAemia after transplantation. However, there is little evidence to guide this strategy; nor is there consensus concerning either the best specimen to use for EBV analysis (whole blood or plasma) or the appropriate clinical action to take if EBV DNAemia is detected.
Our aim is to estimate the incidence and clinical consequences of Epstein-Barr virus (EBV) DNAemia in whole blood and plasma in renal transplant recipients, and to determine if persistence of EBV DNAemia can predict excessive immunosuppression as indicated by the incidence of infections requiring hospitalisation, EBV driven PTLD and mortality.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 2 years of age receiving a kidney transplant from a living or deceased donor.
- •Adults 18 years or older who receive a kidney transplant from a living or deceased donor.
- •Capable of giving written informed consent to participation in the study (legal guardians capable of giving written informed consent to participation in the study in case of children younger than 18 years old).
排除标准
- •Patients unable to comply with the study requirements.
- •Withdrawal of consent.
结局指标
主要结局
The incidence rate of EBV driven PTLD
时间窗: 2 years
The incidence rate of EBV driven PTLD in patients with 2 consecutive positive PCR samples for EBV DNA in whole blood and/or plasma during follow up (persistent EBV DNAemia). The detection level for EBV DNA in the whole blood is 110 IU/ml. Levels of EBV DNA \< 1000 IU/ml are not quantified. The lower limit of detection for the EBV DNA plasma analysis is 25 IU/ml. Levels of EBV \< 100 IU/ml are not quantified
The incidence rate of infections requiring hospitalisation in patients with persistant EBV DNAemia
时间窗: 2 years
The incidence rate of infections requiring hospitalisation in patients with 2 consecutive positive PCR samples for EBV DNA in whole blood and/or plasma during follow up (persistent EBV DNAemia).
Mortality rate in patients with persistant EBV DNAemia
时间窗: 2 years
Mortality rate in patients with 2 consecutive positive PCR samples for EBV DNA in whole blood and/or plasma during follow up (persistent EBV DNAemia).
次要结局
- Incidence of infections requiring hospitalisation(2 years)
- Incidence of acute rejection(2 years)
- The incidence of symptomatic opportunistic infections(2 years)
- Kidney graft function(2 years)
- Incidence of EBV driven PTLD during follow-up.(2 years)