German Register of Outpatient Parenteral Antibiotic Therapy (OPATReg)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Clara Lehmann, Prof.; Phone Number: +4922147839684; Email: clara.lehmann@uk-koeln.de
• Study Contact Backup: Name: Charlotte Leisse; Phone Number: +4922147842895; Email: charlotte.leisse@uk-koeln.de

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • University Hospital of Cologne
    • Contact: Clara Lehmann, Prof.; Email: clara.lehmann@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults getting OPAT in one of the participating study sites

Description

Inclusion Criteria:

• patients who get OPAT

Exclusion Criteria:

• patients who don't get OPAT

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-effects of treatment and catheter-related infections	12 weeks
Number of Hospitals being able to apply OPAT	Feasibility of OPAT under differing hospital specific circumstances	12 weeks

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Study Chair: Clara Lehmann, Prof., Head of Outpatient Department in ID, University Hospital of Cologne

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: OPATReg

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