A Retrospective, Post-Marketing, Sentinel-based Active Surveillance Study to Evaluate the Safety of Ampholipad Using Real-World Data in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 6
- 主要终点
- Incidence of nephrotoxicity
研究概览
简要总结
A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad.
详细描述
A retrospective, post-marketing, multi-center chart review study includes patients who had been prescribed Ampholipad in selected sentinel hospitals in Taiwan. Medical charts of approximately 100 treated patients will be reviewed by the investigators to collect the pre-specified data, including indication, underlying cancer type (only for cancer patients), demographics, and concomitant medications as well as all the laboratory examination data regarding renal function from 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 2 years of age
- •Patients who had received at least one dose of Ampholipad treatment, with available baseline serum creatinine (SCr) data within 1 month prior to first Ampholipad use and at least one post baseline SCr data during treatment period
排除标准
- •Patients whose medical chart cannot provide both the start and stop dates of Ampholipad for a course of treatment (first course only)
- •Patients who had documented HIV infection diagnosis
- •Patients with potential end-stage renal disease (ESRD) receiving regular dialysis within 1 month prior to first Ampholipad use
结局指标
主要结局
Incidence of nephrotoxicity
时间窗: Ampholipad treatment course, up to 42 days
Nephrotoxicity is defined as an increase in serum creatinine (SCr) to \>2X baseline value and the post-baseline peak SCr \> 1.2 mg/dL
次要结局
- Incidence of Adverse Drug Reaction (ADR)(From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course)
- eGFR(From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course)
- Proportion of SCr >1.5X, SCr >2X or SCr >3X of the baseline values(From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course)
- Fever resolution rate(From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course)
- Survival rate(From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course)
- Microbiological eradication rate(From 1 month prior to first dose of Ampholipad up to 1 week after the last dose of the initial treatment course)