EUCTR2014-005030-54-Outside-EU/EEA进行中（未招募）不适用
A Multicenter, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia - PK Study in Immunocompromised Young Kids w/ Febrile 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
- 32
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
- •The patient is 3 to 24 months of age with one or more of the following conditions:
- •1) leukemia, lymphoma, or other cancers
- •2) bone marrow or peripheral stem transplantation
- •3) high dose chemotherapy incurring prolonged neutropenia
- •4) aplastic anemia
- •Patient has an absolute neutrophil count <500/mm3 (Note: The patient should have an anticipated duration of neutropenia of =10 days.) AND at least 1 recording of fever >38.0°C (oral or tympanic calibrated to oral) within 72 hours of screening.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 9
- •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
- •Patient is <3 months or >24 months (2 years) of age (at time of drug administration).
- •Patient has proven or probable invasive fungal infection at the time of
- •Patient is taking systemic antifungal therapy with the exception of prophylactic fluconazole.
研究者
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