Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Predictive values of Cytomegalovirus infection
研究概览
简要总结
Cytomegalovirus (CMV) infection was observed in over 30% of organ recipients with high morbidity. Moreover, no prophylaxis, 75% R + D-transplanted, 55%, R + D + and D-25% R + develop CMV. The number of available antiviral drugs is reduced and noticeable side effects (neutropenia, renal toxicity) lead to premature discontinuation of therapy or the use of reduced doses that promote non-response to treatment and the emergence of resistance. In case of neutropenia, there are more an increased risk of secondary rejection due to the reduction of immunosuppressive treatment rendered necessary by the haematological reached.
Rational use of these molecules is necessary with essential today as the optimal duration of prophylaxis primary issues and the prophylaxis of recurrences in case of CMV infection reported in.
详细描述
QuantiFERON-CMV ® is a fast and standardized test that evaluates the CMV specific cellular immunity measuring the amount of secreted Interferon gamma (IFN gamma) in plasma by ELISA. It uses more epitopes of proteins including CMV glycoprotein B (gB), protein IE-1 and protein pp65 and protein pp50, which are specific for (human leukocyte antigen) HLA class I. Pretreatment of the sample is simple and plasma can be stored, frozen, for a delayed dose of interferon.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant recipient
- •Immunized against the Cytomegalovirus
排除标准
- •Not willing to participate, no health insurance
- •clinical evidence of active viral infection
- •renal transplant recipient whose treatment includes induction antilymphocyte antibodies
研究组 & 干预措施
CMV infection
Renal transplant recipient immunized against the Cytomegalovirus
干预措施: CMV Infection (Biological)
结局指标
主要结局
Predictive values of Cytomegalovirus infection
时间窗: 1 week
CMV infection defined by a positive ADNémie confirmed on a second sample ideally one week apart.
次要结局
- No response to treatment(21 days)