Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne

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.

Study Overview

• Status: Recruiting
• Conditions: Implementation of OPAT in Germany
• Intervention / Treatment: Procedure: Outpatient Parenteral Antibiotic Therapy

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • University of Cologne
    • Contact: Clara Lehmann, MD; Phone Number: +4922147888835; Email: clara.lehmann@uk-koeln.de
    • Principal Investigator: Lehmann Clara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

primary care clinic, university hospital

Description

Inclusion Criteria:

• patients who get OPAT

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cologne

Publications and helpful links

General Publications

• Scholten N, Leisse C, Brandes V, Oberrohrmann C, Ihle P, Peter S, Hagemeier A, Hellmich M, Lindemann CH, Samel C, Pfaff H, Lehmann C. Outpatient parenteral antimicrobial therapy in Germany: a prospective cohort study protocol. BMJ Open. 2022 Nov 14;12(11):e061417. doi: 10.1136/bmjopen-2022-061417.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: implementation; infectious diseases; OPAT
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: C-OPAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No