Retrospective Observational Study Of Patients Previously Treated With Tigecycline In ICU And Included In The Previous French Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline
研究概览
简要总结
The goal of this retrospective observational study is to collect only status survival data 30 days after the last dose of treatment of patients included in the initial protocol WYETH 3074A1-4448 / B1811030. The purpose is to estimate the survival status, 30 days after the last intake of tigecycline to patients hospitalized in ICU and treated by tigecycline.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients included in the previous study WYETH 3074A1-4448 then Pfizer B1811030 for which mortality status was not known at the closure of this previous study
排除标准
- •Patients who has withdrawn their consent for the study WYETH3074A1-4448 then Pfizer B1811030.
结局指标
主要结局
Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline
时间窗: 30 days after last dose of Tigecycline (Day 108)
Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants' data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported.
次要结局
未报告次要终点