A Randomized Phase II, Multi-center, Non-inferiority Clinical Trial for Efficacy and Safety of Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 7
- 主要终点
- Responses to therapy
研究概览
简要总结
This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. The investigators evaluate efficacy and safety of micafungin sodium (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a control and this study is prospective, randomized, non-inferiority trials.
Therefore, this study was planned for review of the safety and efficacy in korean patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The male and female patients over 18 years
- •To participate in clinical trials and voluntary written consent requirement to comply with a patient
- •Chemotherapy with a variety of hematologic malignancies or patients undergoing stem cell transplantation
- •Fever (temperature ≥ 38.4 ℃) showing Neutropenia (absolute neutrophil count <500/mm3) patients
- •Combined antibiotic therapy 72 hours after the expiration of term lasts three patients
排除标准
- •Of clinical trials of breast-feeding or pregnant women of childbearing age with intent to
- •Adapted species (candida genus, aspergillus genus) Colitis caused by fungi other than the patients with fungal infection
- •HIV-positive patient serum
- •This test within 30 days of assignment to the other patients participating in clinical trials
- •Within 72 hours of registration before the patients treated with systemic antifungal agents
研究组 & 干预措施
Arm A
Micafungin sodium
干预措施: Micafungin sodium (Drug)
Arm B
Itraconazole
干预措施: Itraconazole (Drug)
结局指标
主要结局
Responses to therapy
时间窗: 7 days after stopping study medication
1. definition of 'treatment success': (5 Items to meet all your success) * Within 7 days after stopping study medication if there is no fungal infection * 7 days after stopping study medication if you are alive * Neutropenia period of serious adverse events or lack of effective medication is not stopped * If fever during neutropenia (temperature \<37.5 ℃) * Treatment until the end of the existing fungal infection is treated completely or partially 2. definition of 'treatment failure': - If you failed any of 5 Items in 'treatment success'
次要结局
未报告次要终点