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临床试验/NCT02784756
NCT02784756已完成不适用

Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study

University Health Network, Toronto6 个研究点 分布在 2 个国家目标入组 134 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

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

Other

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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