NCT03933748招募中不适用
Therapeutic Drug Monitoring of Teicoplanin in Children
Shandong University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Plasma drug concentration
研究概览
简要总结
In this study, the therapeutic drug monitoring of teicoplanin is carried out among children to obtain the drug concentration, clinical efficacy and safety data of children patients in different gender and age groups. Then we analyze the relationship between blood drug concentration and efficacy and safety, and provide recommendations for the treatment window of teicoplanin in Chinese children.
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
- •Teicoplanin was administered intravenously;
- •Teicoplanin was used for therapeutic purposes;
- •Age:≤18 years;
- •Clinician confirms and plans to diagnose the patient with gram-positive coccus infection;
- •Patients with therapeutic concentration monitoring of teicoplanin.
排除标准
- •Teicoplanin was administered non-intravenously;
- •Teicoplanin was used for prophylactic purposes;
- •Patients without therapeutic concentration monitoring of teicoplanin;
- •Patients who die within 24 hours of the use of teicoplanin；
- •The blood concentrations of the patient was not approved by the quality control center.
结局指标
主要结局
Plasma drug concentration
时间窗: Through study completion, an average of 14 days
To detect the plasma concentrations of teicoplanin at therapeutic drug monitoring (TDM).
次要结局
未报告次要终点
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University
研究点 (1)
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