Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne

Recruiting

• Conditions: Implementation of OPAT in Germany
• Interventions: Procedure: Outpatient Parenteral Antibiotic Therapy

• Registration Number: NCT04002453
• Lead Sponsor: University of Cologne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-06-28
• Study Start: 2020-07-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-07
• Last Update Posted: 2022-09-08
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients who get OPAT

Exclusion Criteria

• patients who don't get OPAT or are not capable to give their informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outpatient parenteral antimicrobial therapy	Outpatient Parenteral Antibiotic Therapy	Patients with an infectious disease that receive an outpatient parenteral antimicrobial therapy

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Cologne; 🇩🇪 Cologne, Germany