Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 27
- 主要终点
- Proportion of participants developing a RVI within one-year post transplant.
研究概览
简要总结
The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT).
Primary Objective
To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors.
Secondary Objectives:
- To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors.
- To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .
详细描述
The investigators will collect a nasal swab and blood sample from the participant when the participant is enrolled on the study and if the participant develops a RVI in the first year after transplant. The investigators will collect a blood sample 100 days after the participant's transplant.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Recipient Exclusion Criteria
- •Donor Exclusion Criteria
- •Is not an HCT donor for a participant enrolled on the VIPER study.
- •Not available to provide pre-transplant research blood sample.
结局指标
主要结局
Proportion of participants developing a RVI within one-year post transplant.
时间窗: Baseline through 1-year post-transplant
Prevalence is estimated as the proportion of HCT or SOT participants with a positive PCR pre-transplant screen who develop any RVI within one year post transplant. A 95% confidence interval will be provided.
次要结局
- Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant(1 year)
- Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant.(Day +100 through 1-year post-transplant)