Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- CMV Viremia-Free Survival
研究概览
简要总结
The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
- •Pre-existing serological immunity to CMV (R+)
- •Able and willing to provide informed consent
排除标准
- •Anti-thymocyte globulin induction immunosuppression
- •Perioperative desensitization
- •Pregnant or breastfeeding women
研究组 & 干预措施
Lung Transplant Recipients
Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded.
干预措施: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP) (Device)
Lung Transplant Recipients
Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded.
干预措施: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay (Diagnostic Test)
Lung Transplant Recipients
Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded.
干预措施: Valganciclovir (Drug)
结局指标
主要结局
CMV Viremia-Free Survival
时间窗: Up to Month 12 Post-Transplant
Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood.
次要结局
- Incidence of Aspergillus Infection(Up to Month 12 Post-Transplant)
- Incidence of CMV Viremia Requiring Treatment(Up to Month 12 Post-Transplant)
- Incidence of Bacterial Pneumonia(Up to Month 12 Post-Transplant)
- Incidence of CMV Viremia(Up to Month 12 Post-Transplant)
- Incidence of Treatment-Resistant CMV Viremia(Up to Month 12 Post-Transplant)
- Incidence of Varicella Zoster Reactivation(Up to Month 12 Post-Transplant)
- Incidence of Neutropenia(Up to Month 12 Post-Transplant)