Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents With Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The PTAs of AUC24/MIC90 for C. albicans , C. glabrata , and C. parapsilosis
研究概览
简要总结
Caspofungin (CAS) is used to prevent and treat invasive fungal infections patients older than 3 months. However, the optimal dosing strategy of CAS is lacking in adolescents from 12 to 17 years old, especially those undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), who are vulnertable to fungal infections. The study aimed to establish a population pharmacokinetic (PPK) model and assess the dosing schemes of CAS in adolescents with allogeneic hematopoietic stem cell transplantation (allo-HSCT).
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The adolescents (12 - 17 years) underwent allo-HSCT
- •Use caspofungin for the prevention or treatment of fungal infections
排除标准
- •Intolerable to caspofungin
- •Participate into other clinical studies
- •There are conditions that researchers do not consider it appropriate to join the research.
结局指标
主要结局
The PTAs of AUC24/MIC90 for C. albicans , C. glabrata , and C. parapsilosis
时间窗: 1 day
The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC90 (the lowest concentration of caspofungin at which 90% of the isolates were inhibited) (AUC24/MIC90) for C. albicans (0.06 mg/L), C. glabrata (450 mg/L), and C. parapsilosis (1185 mg/L) .
The PTAs of trough concentration
时间窗: the trough concentration (24 hours after administration) at the steady state
PTA of patients with CAS trough concentration ≥ 1 μg/mL
The PTAs of AUC24/MIC for various species of Candida spp isolates
时间窗: 1 day
The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC (minimal inhibitory concentration) (AUC24/MIC) for various species of Candida spp isolates with a MIC range of 0.03 to 1.0 mg/L
次要结局
未报告次要终点
研究者
Wei Zhao
professor
Shandong University