From the *Duke Clinical Research Institute, Duke University, Durham, NC; †University of California, Los Angeles, CA; ‡Astellas Scientific and Medical Affairs, Inc.; §Astellas Pharma Global Development, Inc., Northbrook, IL; and ¶Children's Hospital of Orange County, Orange, CA.
Pediatr Infect Dis J. 2013 Nov;32(11):e419-25. doi: 10.1097/INF.0b013e31829efd14.
Micafungin is an echinocandin with proven efficacy against a broad range of fungal infections, including those caused by Candida spp.
To evaluate the safety and pharmacokinetics of once-daily 3 mg/kg and 4.5 mg/kg micafungin in children with proven, probable or suspected invasive candidiasis.
Micafungin safety and pharmacokinetics were assessed in 2 phase I, open-label, repeat-dose trials. In Study 2101, children aged 2-16 years were grouped by weight to receive 3 mg/kg (≥25 kg) or 4.5 mg/kg (<25 kg) intravenous micafungin for 10-14 days. In Study 2102, children aged 4 months to <2 years received 4.5 mg/kg micafungin. Study protocols were otherwise identical.
Safety was analyzed in 78 and 9 children in Studies 2101 and 2102, respectively. Although adverse events (AEs) were experienced by most children (2101: n=62; 2102: n=9), micafungin-related AEs were less common (2101: n=28; 2102: n=1), and the number of patients discontinuing due to AEs was low (2101: n=4; 2102: n=1). The most common micafungin-related AEs were infusion-associated symptoms, pyrexia and hypomagnesemia (Study 2101), and liver function abnormalities (Study 2102). The micafungin pharmacokinetic profile was similar to that seen in other studies conducted in children, but different than that observed in adults.
In this small cohort of children, once-daily doses of 3 mg/kg and 4.5 mg/kg micafungin were well tolerated. Pharmacokinetic data will be combined in a population pharmacokinetic analysis to support US dosing recommendations in children.
米卡芬净是一种棘白菌素类药物，对广泛的真菌感染具有疗效，包括念珠菌属引起的感染。
评估每日一次 3 mg/kg 和 4.5 mg/kg 剂量米卡芬净在确诊、疑似或可能患有侵袭性念珠菌病的儿童中的安全性和药代动力学。
在两项 I 期、开放标签、重复剂量试验中评估米卡芬净的安全性和药代动力学。在研究 2101 中，根据体重将 2-16 岁的儿童分为 3 mg/kg（≥25 kg）或 4.5 mg/kg（<25 kg）静脉滴注米卡芬净组，治疗 10-14 天。在研究 2102 中，4 个月至<2 岁的儿童接受 4.5 mg/kg 米卡芬净。研究方案基本相同。
安全性分析纳入了研究 2101（n=78）和 2102（n=9）的 78 名和 9 名儿童。尽管大多数儿童出现了不良事件（AE）（2101：n=62；2102：n=9），但米卡芬净相关 AE 较少（2101：n=28；2102：n=1），因 AE 停药的患者人数较少（2101：n=4；2102：n=1）。最常见的米卡芬净相关 AE 为输液相关症状、发热和低镁血症（研究 2101）和肝功能异常（研究 2102）。米卡芬净的药代动力学特征与在儿童中开展的其他研究相似，但与成人观察到的药代动力学特征不同。
在这一小部分儿童队列中，每日一次 3 mg/kg 和 4.5 mg/kg 剂量的米卡芬净耐受良好。药代动力学数据将在群体药代动力学分析中进行合并，以支持美国在儿童中的剂量建议。
