Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne
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|ClinicalTrials.gov Identifier: NCT04002453|
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : June 1, 2020
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.
|Condition or disease||Intervention/treatment|
|Implementation of OPAT in Germany||Procedure: Outpatient Parenteral Antibiotic Therapy|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||120 participants|
|Target Follow-Up Duration:||6 Weeks|
|Official Title:||Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||August 15, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Outpatient parenteral antimicrobial therapy
Patients with an infectious disease that receive an outpatient parenteral antimicrobial therapy
Procedure: Outpatient Parenteral Antibiotic Therapy
Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.
- Number of Patients with effective OPAT [ Time Frame: 12 weeks ]Successful administration and completion of the antiinfective therapy
- Number of Patients With Treatment-Related Adverse Events [ Time Frame: 12 weeks ]side-effetcs of treatment and catheter-related infections
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002453
|University of Cologne||Recruiting|
|Cologne, Germany, 50937|
|Contact: Clara Lehmann, MD +4922147888835 firstname.lastname@example.org|
|Principal Investigator: Lehmann Clara, MD|