Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The peak plasma drug concentration of cefuroxime
研究概览
简要总结
Cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. However, population pharmacokinetic，effectiveness and safety data for cefuroxime in neonates are lacking. The aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates.
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
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: postnatal age ≤28 days;
- •Cefuroxime used as part of antimicrobial treatment;
- •Parental written consent.
排除标准
- •Expected survival time less than the treatment cycle;
- •Receiving other systemic trial drug therapy;
- •Other factors that the researcher considers unsuitable for inclusion.
结局指标
主要结局
The peak plasma drug concentration of cefuroxime
时间窗: at (5-10) minutes after intravenous administration
To detect the peak plasma drug concentration of cefuroxime after intravenous administration.
The random plasma drug concentration of cefuroxime
时间窗: at (0.25-10) hours after intravenous administration.
To detect the random plasma drug concentration of cefuroxime after intravenous administration.
The trough plasma drug concentration of cefuroxime
时间窗: at 1-2 hours before the next administration
To detect the trough plasma drug concentration of cefuroxime after intravenous administration.
The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC)
时间窗: Through study completion, an average of 3 days
PD target
Adverse events
时间窗: Through study completion, an average of 15 days
Drug-related adverse events and serious adverse events
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