NCT00607763已完成1 期
A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 主要终点
- Evaluation of Micafungin pharmacokinetics
研究概览
简要总结
Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed
详细描述
This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥4 months to < 24 months
- •Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
- •Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables
排除标准
- •Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase > 5 times the upper limit of normal (ULN)
- •Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
- •Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
- •Subject has received treatment with an echinocandin within one week prior to first dosing
- •Subject status is unstable and subject is unlikely to complete all study required procedures
研究组 & 干预措施
1. Micafungin
Experimental
干预措施: Micafungin (Mycamine) (Drug)
结局指标
主要结局
Evaluation of Micafungin pharmacokinetics
时间窗: 10 - 14 Days
次要结局
- Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation(Day 1 to End of Study)
研究者
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