Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 6
- 主要终点
- Symptomatic CMV disease
研究概览
简要总结
The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.
详细描述
Cytomegalovirus (CMV) disease is an important cause of morbidity in solid organ transplantation recipients and remains the most common opportunistic viral infection in these patients. Standard CMV prevention strategies include universal prophylaxis and pre-emptive therapy with viral load monitoring. However, neither of these strategies has been successful in eliminating CMV disease as seen by high rates of viremia, incidence, and CMV recurrence despite treatment. Recently, the Quantiferon-CMV assay has been shown to predict late CMV reactivation after prophylaxis and to be predictive of viral progression and the need for antiviral therapy in organ transplant recipients who develop low level CMV viremia. The purpose of the current study is to test the clinical strategy of using the Quantiferon-CMV assay in guiding the duration of primary CMV prophylaxis in solid organ transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Adult kidney, kidney-pancreas, liver transplant recipient, or heart transplant recipient
- •CMV D+/R- patient or any R+ patient who received antithymocyte globulin induction therapy
排除标准
- •Unable to comply with protocol
- •Campath (Alemtuzumab) induction
- •Receiving another investigational compound for CMV treatment or prophylaxis.
- •Allergy to valganciclovir or ganciclovir
- •Receiving an investigational compound for prevention or treatment of rejection, or participating in another interventional study
研究组 & 干预措施
Quantiferon-CMV assay
All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design
干预措施: Quantiferon-CMV assay (Device)
结局指标
主要结局
Symptomatic CMV disease
时间窗: 1 year
Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.
次要结局
- Occurrence of CMV viremia(1 year)
- positive vs. negative cell-mediated immunity assays(1 year)
