Xydalba Utilization Registry in Germany

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追踪信息

首次提交日期 ^ICMJE

May 9, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

June 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Prevalence of ABSSSI and other primary diagnoses among patients who received Xydalba (dalbavancin) as treatment for this primary diagnosis[ Time Frame: Day of first dose ]

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Clinical response[ Time Frame: at 30 days after first dose ]
Clinical response by cured, improved, failure, non-evaluable, worsening or other (non-clinically evaluable)
Clinical response by diagnosis[ Time Frame: at 30 days after first dose ]
Clinical response by diagnosis (ABSSSI, Gram-positive bacteremia, other associated diagnosis)
Time from Xydalba treatment onset to clinical response[ Time Frame: up to 30 days after first dose ]
Adverse Events, Adverse Drug Reactions and Special Situations[ Time Frame: up to 30 days after first dose ]

描述性信息

简略标题 ^ICMJE

Xydalba Utilization Registry in Germany

正式标题 ^ICMJE

Xydalba Utilization Registry: A Multicenter, Prospective and Retrospective Registry to Characterize the Use of Xydalba

简要概况

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.

详细说明

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 and retrospective registry of adult patients treated with Xydalba in Germany. All Adverse events (AEs) (serious and non-serious; special situations; related and not-related, collected prospectively or retrospectively) will be recorded in the eCRF. Treatment related AEs and SAEs will be reported to the healthcare authorities, as requested by local regulations and according to current Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2). TEST PRODUCT (S), DOSE, AND MODE OF ADMINISTRATION Xydalba (dalbavancin) as prescribed by the physician according to clinical practice. RATIONALE This prospective and retrospective registry is designed to capture information about the clinical use of Xydalba, its safety and effectiveness, characteristics of the patient, disease, pathogen, clinical course, treatment course, and hospitalization. This registry will capture the data in real world setting on patients who received Xydalba.

研究类型 ^ICMJE

Observational

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Xydalba
Information will be recorded about Xydalba administration (e.g. dose(s), number of infusions, length of infusions, dates or schedule of administration, sites of administration [e.g. hospital, ICU]), and reason for discontinuation, including response to treatment to assess whether the patient was clinically improving when Xydalba was discontinued

研究工具

: 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

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

150

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

August 2020

预计主要完成日期

June 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria A patient must meet all of the following criteria to be eligible for participation in the study. 1. Male and female patient, ≥18 years of age at the time of receipt of Xydalba. 2. The patient received at least one infusion of Xydalba. 3. Patient signed the consent form Exclusion Criteria A patient who meets the following criterion is not eligible for participation in the study. 1. The patient was enrolled in a clinical trial in which treatment for Xydalba is managed through a protocol.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Germany

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Correvio

合作者 ^ICMJE

研究员 ^ICMJE

Study Director: Kiran Bhirangi, MBBS FRCS I Correvio

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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