NCT01982071终止4 期
A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (CFDA Commitment)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 59
- 主要终点
- Overall success rate
研究概览
简要总结
To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
- •The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
- •The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:
- •Risk factor (s) of infection
- •Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
- •Two or more positive sputum culture for Candida
排除标准
- •Patient received any other antifungal drug within 1 month prior to enrollment.
- •HIV positive patient
- •Patients with organ transplant
- •Patients with agranulocytosis
研究组 & 干预措施
Treatment group
Experimental
Intravenous (IV)
干预措施: Micafungin (Drug)
结局指标
主要结局
Overall success rate
时间窗: up to 8 weeks
success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment)
次要结局
- Safety assessed by the incidence of adverse events(up to 10 weeks)
研究者
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