Study of the Clinical Benefits of Different Formulations of Amphotericin B
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Overall Adverse Reaction Rate
研究概览
简要总结
This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug selection, and provide evidence-based evidence in support of rational clinical drug use.
详细描述
The researchers selected patients with amphotericin B use records discharged from five tertiary hospitals across the country from January 1, 2020 to the present, extracted data according to the inclusion and exclusion criteria, and divided them into experimental and control groups, in order to understand the current status of amphotericin B use in each preparation type, compare the differences in the safety and efficacy of the various preparations in the domestic clinical application, and provide real-world evidence of the choice of clinical medication.
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
- •Patients discharged from January 1, 2020 to the present;
- •Patients with a record of amphotericin B use.
排除标准
- •1.Key information missing from patient studies.
结局指标
主要结局
Overall Adverse Reaction Rate
时间窗: Through study completion,up to half a year.
The incidence of total adverse reactions was analyzed to assess the difference in safety of amphotericin B by formulation type in domestic clinical application, to provide real-world evidence for clinical drug selection, and to provide evidence-based evidence in support of rational clinical drug use.
Pathogen clearance rate
时间窗: Through study completion,up to half a year.
To assess the differences in effectiveness of amphotericin B by formulation type in domestic clinical application by analyzing the pathogen clearance rate, to provide real-world evidence for clinical dosing selection, and to provide evidence-based evidence to support rational clinical dosing.
次要结局
未报告次要终点
研究者
Rui Yang
Associate professor of pharmacy
Qianfoshan Hospital