NCT00818584已完成1 期
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
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
- 13
- 主要终点
- Assessment of micafungin plasma pharmacokinetic parameters
研究概览
简要总结
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection
详细描述
Subjects will be stratified by weight to receive one of two doses of study drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 48 Hours 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry
- •Infant has sufficient venous access to permit study drug dosing
- •Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry
排除标准
- •Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
- •Infant has received an echinocandin within one month prior to study entry
- •Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk
- •Infant has a life expectancy of less than 96 hours
研究组 & 干预措施
1. micafungin lower dose
Experimental
干预措施: Micafungin (Drug)
2. micafungin higher dose
Experimental
干预措施: Micafungin (Drug)
结局指标
主要结局
Assessment of micafungin plasma pharmacokinetic parameters
时间窗: Day 4
次要结局
- Monitor adverse events(11 or 12 Days)
研究者
相似试验
进行中（未招募）
1 期
A Study of Selumetinib in Chinese Paediatric and Adult Subjects With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas (PN)Neurofibromatosis 1Neurofibroma PlexiformNCT04590235AstraZeneca32
已完成
1 期
A Study of MEHD7945A in Combination With Cisplatin and 5-Fluorouracil (5-FU) or Paclitaxel and Carboplatin in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)Head and Neck CancerNCT01911598Genentech, Inc.24
已完成
1 期
Phase 1 Study of Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody in Solid TumorsMetastatic Adenocarcinoma of the Colon or RectumMalignant Solid TumorsNCT01765790Baxalta now part of Shire68
进行中（未招募）
1 期
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid TumorsOvarian CancerGastric CancerNCT06714617SystImmune Inc.120
终止
1 期
A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 MutationNCT06560645Prelude Therapeutics42