DART: "Sivextro® in Acute Bacterial Skin anD Skin Structure Infection (ABSSSI) in Hospitalized Patients. A Global ObseRvational STudy."
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 108
- 主要终点
- Number of treatment days
研究概览
简要总结
This open-label, prospective, multi-center, non-interventional, observational, parallel cohort study intended to provide real life data on the treatment duration, effectiveness and safety of tedizolid and linezolid when treating ABSSSI hospitalized patients in a real practice setting.
详细描述
The primary objective of this study was to assess the treatment duration in the real life in 2 cohorts consisting of patients treated by 200 mg once daily IV/PO tedizolid or treated by 600 mg twice daily IV/PO (intravenous/per oral) linezolid.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult female and male in-patients with clinical diagnosis compatible with ABSSSI (cellulitis/erysipelas, major skin abscess or wound infections) with a clinical suspicion of infection by Gram positive bacteria (with or without laboratory confirmation).
- •Patients for whom the decision to initiate treatment with tedizolid phosphate or linezolid was made as per physician's routine treatment practice.
- •Signed informed consent.
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice.
- •Patients who have been enrolled in this study before.
研究组 & 干预措施
Tedizolid
Hospitalized ABSSSI patients treated with tedizolid
干预措施: Tedizolid (Sivextro, BAY1192631) (Drug)
Linezolid
Hospitalized ABSSSI patients treated with linezolid
干预措施: Linezolid (Drug)
结局指标
主要结局
Number of treatment days
时间窗: Up to 1 month
Duration of treatment is defined as the time interval from date of first administration of tedizolid or linezolid to the date of permanent discontinuation of tedizolid or linezolid, respectively. The treatment is according to the recommendations written in the local product information.
次要结局
- Number of participants with adverse events or safety-relevant changes in laboratory parameters(Up to 1 month)