Xydalba Utilization Registry: A Multicenter, Prospective and Retrospective Registry to Characterize the Use of Xydalba
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis
研究概览
简要总结
This observational study will collect data on the use of the drug Xydalba® in daily clinical practice in Germany. Such observational studies are also referred to as registries. The sponsor of the study is Correvio International Sárl, based in Switzerland.
Xydalba® contains the active substance dalbavancin, a remedy for a certain type of bacterial pathogens (so-called "gram positive bacteria") which cause the disease. Active ingredients against bacteria are also called antibiotics.
Correvio wants to know which patients received the drug and how the disease went. The treatment places where you got Xydalba, ie clinic, intensive care unit or elsewhere should be recorded. In addition, it is important in this type of medication to track whether the pathogens are changing in any way. Any safety-relevant events (such as side effects) that have occurred during treatment should be investigated by the sponsor and submitted to the competent European authorities.
详细描述
OBJECTIVES
The objectives of this registry are as follows:
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To determine the following characteristics in patients who received intravenous Xydalba administration:
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Patient characteristics.
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Disease characteristics.
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Pathogen characteristics.
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To characterize the usage of Xydalba.
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To characterize the patient's residence and, in hospitalized patients, the lengths of hospital and intensive care unit (ICU) stays, and the destination upon hospital discharge.
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To assess the response of Xydalba treatment, based on clinician determination.
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To characterize the major healthcare resource utilization (HRU) of patients treated with Xydalba.
REGISTRY DESIGN This is a multicenter, prospective and retrospective registry of adult patients treated with Xydalba in Germany.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
use of Xydalba, >18 years
Male and female patients, ≥18 years of age at the time of receipt of Xydalba. Patients who received at least one Xydalba administration in Germany
干预措施: Xydalba (Drug)
结局指标
主要结局
Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis
时间窗: Day of first dose
次要结局
- Time from Xydalba treatment onset to clinical response(up to 30 days after first dose)
- Adverse Events, Adverse Drug Reactions and Special Situations(up to 30 days after first dose)
- Clinical response(at 30 days after first dose)
- Clinical response by diagnosis(at 30 days after first dose)