EUCTR2014-004910-27-Outside-EU/EEA进行中（未招募）不适用
A Multicenter, Noncomparative, Open-label Study to Estimate the Safety, Efficacy, and Pharmacokineticsof MK-0991 (Caspofungin) in Japanese Children and Adolescents with Documented Candida orAspergillus Infections - Japanese Children & Adolescents New Onset Fever & Neutropenia
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female Japanese patient between the ages of 3 months and 17 years at the time when informed consent was obtained.
- •Patients in whom a causative fungus was detected before treatment with the study drug or patients with strongly suspected Candida or Aspergillus infections, as defined below for esophageal candidiasis, invasive candidiasis (candidemia or other types of invasive candidiasis), and aspergillosis (invasive aspergillosis, chronic necrotizing pulmonary aspergillosis, or pulmonary aspergilloma).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with mycoses (e.g., Cryptococcus spp., Trichosporon spp., or zygomycetes including Mucor spp.) other than ones due to Candida spp. or Aspergillus spp.
- •Patients who will receive other systemic antifungal agents (indicated for deep-seated fungal infections) for the first time in the screening period.
- •At screening, patients with any of the laboratory abnormalities listed below: (1) Total bilirubin: More than 5 times the upper limit of the normal range (>5 ULN), (2) AST (SGOT) or ALT (SGPT): More than 5 times the upper limit of the normal range (>5 ULN)
研究者
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