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临床试验/NCT04413396
NCT04413396Unknown不适用

German Register of Outpatient Parenteral Antibiotic Therapy

University of Cologne1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
Number of Patients With Treatment-Related Adverse Events

研究概览

简要总结

Many infectious diseases require a therapy that is administered intravenously due to a lack of oral treatments. Affected patients often have to stay weeks or even months in hospital just for receiving their therapy although they do not feel severely unwell.

Outpatient parenteral antibiotic therapy (OPAT) allows these patients under certain requirements to get discharged from hospital and apply the antibiotic treatment on their own. For these patients quality of life improves by feeling more comfortable at home and being able to participate in everyday life or even go back to work. For the hospitals a reduced inpatient health care means a clear reduction of costs.

The aim of OPATReg is to examine under which conditions the OPAT can be established at different locations of patient care. For this purpose, patients with APAT are to be treated and data collected at 7 university institutions in Germany. All centers have the expertise to provide comprehensive care for patients with infectious diseases, to transfer them from inpatient to outpatient care and to continue to provide care there.

If successful, the project should help to identify the potential of OPAT for all of Germany. If positive effects and feasibility can be demonstrated OPAT could become an important therapy option with many advantages for certain patients.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • patients who get OPAT

排除标准

  • patients who don't get OPAT

结局指标

主要结局

Number of Patients With Treatment-Related Adverse Events

时间窗: 12 weeks

side-effects of treatment and catheter-related infections

Number of Hospitals being able to apply OPAT

时间窗: 12 weeks

Feasibility of OPAT under differing hospital specific circumstances

Number of Patients with effective OPAT

时间窗: 12 weeks

Successful administration and completion of the antiinfective therapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Clara Lehmann

Head of outpatient clinic

University of Cologne

研究点 (1)

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