Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Plasma concentrations of isavuconazole
研究概览
简要总结
The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. The main questions it aims to answer are:
What is the plasma concentration after using isavuconazole in pediatric patients? What is the effective range of plasma concentration of isavuconazole in pediatric patients? What is the safe range of plasma concentration of isavuconazole in pediatric patients? Researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate.
Participants will:
Take drug isavuconazole as prescribed by the doctor;
1mL of blood is drawn 30min before the next dose.
详细描述
Objectives of Study:
Main objective: To monitor the plasma concentration of isavuconazole in children, and to study the pharmacokinetic characteristics of isavuconazole in children, so as to provide basis for the optimization of individualized drug administration.
Secondary objective: To evaluate the relevance of isavuconazole plasma concentrations to efficacy and safety in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who intend to take isavuconazole for the treatment of invasive mycosis;
- •Aged 0-18 years, gender unlimited;
- •The subject and his/her guardian are willing to comply with the procedures and operations specified in the study protocol;
- •The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study.
排除标准
- •The subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug;
- •The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.
研究组 & 干预措施
Isavuconazole group
Theraputic drug monitoring
干预措施: Theraputic drug monitoring (Other)
Isavuconazole group
Theraputic drug monitoring
干预措施: Isavuconazole (Drug)
结局指标
主要结局
Plasma concentrations of isavuconazole
时间窗: 30 minutes before next dosing
High Performance Liquid Chromatography is used to determine the plasma concentrations of isavuconazole
次要结局
- Treatment success rates for IMI(6 months)
- AE and SAE(6 months)
研究者
Juan Wu, PhD
Principal Investigator
Shanghai Children's Medical Center