A Multicenter Cohort Study of the Short and Long-term Safety of Micafungin and Other Parenteral Antifungal Agents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40,110
- 试验地点
- 6
- 主要终点
- Treatment-emergent hepatic injury or dysfunction
研究概览
简要总结
This multicenter observational cohort study proposes to establish the risks of short and long-term outcomes in users of parenteral micafungin and in users of other parenteral antifungal agents from 2005 through 2012 with follow-up until 2017.
详细描述
All eligible patients treated with a parenteral antifungal agent at any time during the years 2005-2012 in each of the participating hospitals, will be included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalized and treated with parenteral antifungal medication
- •first time treatment of the patient with parenteral antifungal in the medical center was anytime from 2005 through 2012
排除标准
- •prior diagnosis of hepatocellular carcinoma
- •had received parenteral antifungal therapy during the 6 months prior to index hospitalization
研究组 & 干预措施
1) parenteral micafungin users
patients who had been treated with parenteral micafungin
干预措施: Parenteral micafungin application (Drug)
2) other parenteral antifungal users
patients who had been treated with a parenteral antifungal agent (not micafungin)
干预措施: Other parenteral antifungal drugs (Drug)
结局指标
主要结局
Treatment-emergent hepatic injury or dysfunction
时间窗: Up to 30 days after termination of the index treatment
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Treatment-emergent renal failure or dysfunction
时间窗: Up to 30 days after termination of the index treatment
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Rehospitalization for the parenteral treatment of fungal infections
时间窗: Up to 30 days after termination of the index treatment
Data will be used of patients treated during the years 2005-2012 with a parenteral antifungal agent in the participating centers.
Death from hepatocellular carcinoma (HCC)
时间窗: Up to 13 years after treatment
On a long-term basis up to 13 years from 2005-2017.
次要结局
未报告次要终点