Anidulafungin PK in Infants and Toddlers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
研究概览
简要总结
This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in infants and toddlers less than 24 months of age with suspected serious infection. There will be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24 hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those observed in older children and adults.
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
- 年龄范围
- 48 Hours 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 24 months at the time of enrollment
- •Patient must have sufficient venous access to permit administration of study medication
- •Infant or toddler suspected to have a serious infection and from whom a blood culture has been obtained with 48 hours of study entry
- •Availability and willingness of the parent/legally authorized representative to provide written informed consent.
排除标准
- •Patients with a history of anaphylaxis attributed to an echinocandin
- •Any other concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study
- •Previous participation in this study
- •Previous exposure to an echinocandin in the month prior to study.
研究组 & 干预措施
Treatment
Treatment
干预措施: Anidulafungin (Drug)
结局指标
主要结局
The Pharmacokinetics (Area Under the Curve) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.
时间窗: 5 days
Area under the curve at steady state
次要结局
- Safety (Participants With Adverse Events) of Anidulafungin in Infants and Toddlers Less Than 24 Months of Age With Suspected Serious Infection.(During and up to 10 days after last dose of study drug.)
研究者
Michael Cohen-Wolkowiez
Assistant Professor, Department of Pediatrics
Duke University