Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Positive rate of FilmArray GI test before and post-HSCT
研究概览
简要总结
This is a prospective single arm study with the study period from June 1st, 2019 to May 31st, 2020. An historical control group will be used in the study, which includes all patients received HSCT but not GI panel detection between June 1st, 2018 to May 31st, 2019. All patients receiving HSCT within the year at SCMC will be enrolled in the study. The stool samples will be collected from each patient at 2-3 time points, including the day before pre-conditioning (T1), 28+-3 days after HSCT (T2), and the day severe diarrhea present (T3). All the stool samples will be detected by the FilmArray GI panel, and the results as well as other clinical information including the laboratory examinations will be recorded and analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age ≤ 18 years old;
- •Receiving HSCT;
- •Legal guardians fully understand and sign informed consent.
排除标准
- •Receiving secondary transplantation;
- •Cannot give informed consent or not willing to enroll the study.
结局指标
主要结局
Positive rate of FilmArray GI test before and post-HSCT
时间窗: 31 days after HSCT
Compare the FilmArray GI test results generated from the same patients in different time points
时间窗: 31 days after HSCT
次要结局
未报告次要终点
研究者
Cao Qing
Director of Infectious Diseases
Shanghai Children's Medical Center