Pharmacokinetics and Pharmacodynamics of Ceftazidime Avitbatan Sodium in Children With Severe Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
研究概览
简要总结
Ceftazidime avitbatan sodium is a broad-spectrum antibiotic with an antimicrobial spectrum covering resistant gram-negative bacteria. Its use in pediatric intensive care for severe infections is not unusual. Pathophysiological changes in severe sepsis can lead to significant changes in pharmacokinetics and pharmacodynamics during continuous renal replacement therapy.This research aims to study change of pharmacokinetic and pharmacodynamic in severe infection children with extracorporeal life support, thus improve the treatment of severe sepsis and sepsis shock.
详细描述
This study is an observational clinical study. Subjects were recruited from children with severe infection receiving ceftazidime avitbatan sodium under routine clinical diagnosis and treatment routine. There is no control, no double-blind randomized design, and the normal treatment schedule of patients was not interfered with, and the disease risk of patients was not increased.All subjects had received at least 5 doses of ceftazidime avitbatan Sodium before enrollment.
Blood sampling time points of ceftazidime avitbatan sodium are listed as follow:
Before administration (0 min); 5,30 min,1 h,2 h,4 h and 8 h after administration, if blood purification is received, one blood sample will be collected before and after the filter at the same time point.
The concentration of ceftazidime avitbatan sodium in whole blood will be analyzed at Huashan Hospital of Fudan University.
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
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who are admitted in the pediatric intensive care unit receiving ceftazidime avitbatan sodium
排除标准
- •No Informed Consent signed
- •Participate in other clinical trials
研究组 & 干预措施
Ceftazidime avitbatan sodiumt group
Children treated with ceftazidime avitbatan sodium in the pediatric intensive care unit will be enrolled in this group. Blood sample will be retained at various time intervals for pharmacokinetics.
干预措施: Ceftazidime Avitbatan Sodium (Drug)
结局指标
主要结局
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
时间窗: Day 1-5
Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug
次要结局
- Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter(Day 1-5)
- AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter(Day 1-5)
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter(Day1-5)
- Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter(Day1-5)