Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne

Study Overview
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Brief Summary
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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 benefits of OPAT are obvious, shown by several studies, and in many countries e.g. the USA OPAT is a very well established way of treatment. In Germany however OPAT is used very infrequently and not in a standardized manner. This is probably due to inadequate knowledge of this form of treatment and deficits in the outpatient care structure, as OPAT is not reflected in the remuneration system of the German health care system despite internationally proven benefits. The aim of this study is to identify and analyze possible obstacles to the implementation of OPAT into the standard patient care in Germany regarding financial, structural and medical limitations. Therefore the investigators intend to treat 120 patients in the metropolitan area of Cologne with OPAT and observe effectiveness, safety, logistics and acceptance to this kind of therapy. If successful, the project should help to identify the potential of OPAT for Germany. If positive effects and feasibility can be demonstrated in the Cologne metropolitan region, OPAT could become an important therapy option with many advantages for certain patients.

Official Title
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Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne

Conditions
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Implementation of OPAT in Germany

Intervention / Treatment
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* Procedure: Outpatient Parenteral Antibiotic Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who get OPAT Exclusion Criteria: patients who don't get OPAT or are not capable to give their informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Outpatient parenteral antimicrobial therapy<br>Patients with an infectious disease that receive an outpatient parenteral antimicrobial therapy | Procedure: Outpatient Parenteral Antibiotic Therapy<br>* Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with effective OPAT | Successful administration and completion of the antiinfective therapy | 12 weeks | 
| Number of Patients With Treatment-Related Adverse Events | side-effetcs of treatment and catheter-related infections | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OPAT, infectious diseases, implementation