NCT03766932Unknown不适用
Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Serum specific IgG, IgM and Mn levels in the enrolled population
研究概览
简要总结
In this study, a multicenter, prospective, synchronous blind, and controlled study was adopted to set the cut-off values of candida specific IgG, IgM, and Mn with the blood culture results as the gold standard, so as to evaluate the diagnostic value of candida specific IgG, IgM, and Mn levels in candida infection.
- the cut-off values of serum specific IgG, IgM and Mn of candida sinensis infected population in China were established by comparing the positive results of blood culture of 300 healthy people and 100 patients with positive candida sinensis blood culture as the gold standard and using ROC curve (ROC curve).
- 100 patients with positive tracheal aspiration culture and 100 patients with positive urine culture were enrolled. Serum levels of candida specific IgG, IgM and Mn were detected, and sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio of candida specific IgG, IgM and Mn in tracheal aspiration and urine were evaluated.
- 200 high risk patients with candida infection were enrolled, and the aseptic fluid culture and the simultaneous detection of serum specific IgG, IgM and Mn were adopted to explore the diagnostic value of the detection method.
- positive candida culture in sputum and positive candida culture in tracheal aspirate were taken as the control group to compare the levels of IgG, IgM and Mn in serum of the two groups, and to explore the diagnostic value of different sampling methods for candida pulmonary infection.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: (1) 18-85 years old; (2) Candida positive in aseptic humoral culture
排除标准
- •(1) no informed consent has been signed; (2) patients with severe immune deficiency -
结局指标
主要结局
Serum specific IgG, IgM and Mn levels in the enrolled population
时间窗: 1-2 years
ELISA was used to detect the samples
次要结局
未报告次要终点
研究者
wang kaifei
xie lixin
Chinese PLA General Hospital
研究点 (1)
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