Telavancin Observational Use Registry (TOUR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,063
- 试验地点
- 1
- 主要终点
- Time to clinical response
研究概览
简要总结
The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.
详细描述
This is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •received at least 1 dose of telavancin since January 1, 2015
排除标准
- •Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015
研究组 & 干预措施
Vibativ
This is an observational study for patients who were already prescribed Vibativ.
干预措施: Vibativ (Drug)
结局指标
主要结局
Time to clinical response
时间窗: 6 months
defined as the number of days between initiation of telavancin therapy and date of cure, where cure is defined as the resolution of the signs and symptoms of infection and/or no need for additional antibiotic therapy, or clearance of the infection with a negative culture result \[Mohr 2009\]
次要结局
- Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs)(30 days)