Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 15
- 主要终点
- Clinical response
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 France. 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:
- To determine the following characteristics in patients who received intravenous Xydalba administration:
- Patient characteristics.
- Disease characteristics.
- Pathogen characteristics.
- To characterize the usage of Xydalba.
- 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.
- To assess the response of Xydalba treatment, based on clinician determination.
- To characterize the major healthcare resource utilization (HRU) of patients treated with Xydalba.
REGISTRY DESIGN:
This is a multicenter, prospective registry of adult patients treated with Xydalba in France.
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
- •Male and female patient associate to a social protection scheme, ≥18 years of age at the time of receipt of Xydalba
- •The patient received at least one infusion of Xydalba
- •Patient signed the consent form
排除标准
- •The patient was enrolled in a clinical trial in which treatment for Xydalba is managed through a protocol.
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 France
干预措施: Xydalba (Drug)
结局指标
主要结局
Clinical response
时间窗: 30 days
Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis
次要结局
- Adverse Events, Adverse Drug Reactions and Special Situations(30 days)
- Clinical response by diagnosis(30 days)
- Time from Xydalba treatment onset to clinical response(30 days)