NCT03127787终止不适用
Clinical Performance Evaluation of DxN CMV Assay
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- virological response to therapy
研究概览
简要总结
The DxN Cytomegalovirus (CMV) assay is an in vitro diagnostic assay intended as an aid in the management of CMV-infected individuals undergoing antiviral therapy. the purpose of the study is to establish the clinical performance of the DxN CMV Assay for plasma samples in the intended use population.
详细描述
same as brief summary
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
- •≥ 18 years old
- •Must have had a kidney transplant and be evaluated for post-transplantation care
- •Must have demonstrated post-transplant CMV DNAemia
- •Must be eligible for and treated with anti-CMV drugs
排除标准
- •HIV positive
- •Proven ganciclovir or valganciclovir resistance
结局指标
主要结局
virological response to therapy
时间窗: 5 months
Resolution of CMV viremia in response to therapy as defined as 2 consecutive negative results
次要结局
未报告次要终点
研究者
研究点 (4)
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