Pharmacokinetics of Itraconazole in Pediatric Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients
研究概览
简要总结
This study investigated repeated-dose pharmacokinetics and safety of itraconazole and its active metabolite hydroxyitraconazole in pediatric cancer patients at risk for the development of invasive fungal disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients who are under chemotherapy, and receive itraconazole.
排除标准
- •Patients with significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.
- •Heart : fractional shortening < 30%, ejection fraction < 45%
- •Liver : total bilirubin ≥ 2 x upper limit of normal (ULN) ; aminotransferase ≥ 3 x ULN
- •Kidney : creatinine ≥ 2 x normal or GFR ≤ 60㎖/min/1.73㎡
- •Patients with hypersensitivity to azoles.
- •Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
- •Pregnant or nursing women.
- •Psychiatric disorder that would preclude compliance.
研究组 & 干预措施
Itraconazole
干预措施: Itraconazole (Drug)
结局指标
主要结局
To investigate repeated-dose pharmacokinetics of itraconazole and its active metabolite hydroxyl itraconazole in pediatric cancer patients
时间窗: 28 days
1. Itraconazole administration 1) Oral for prophylaxis: 2mg/kg/dose,q12hr 2) IV for empirical therapy : After more than 2 days of oral prophylaxis, patients with persistent neutropenic fever / Induction : 5 mg/kg/dose, q12hr X 4 doses / Maintenance : 5 mg/kg/dose,q24hr 2. Sampling 1) During oral : prior to the 5th dose 2) During IV : prior to the every induction and 1-5th maintenance doses, and 1, 2, 4, 8, 12, 24hr after the 3rd IV maintenance 3. Analysis of drug concentrations : Plasma concentrations of itraconazole and hydroxyl-itraconazole are measured using HPLC.
次要结局
- To assess empirical antifungal efficacy and safety in pediatric cancer patients(28 days)