German Register of Outpatient Parenteral Antibiotic Therapy

Implementation of OPAT in Germany Clinical Trial

— OPATReg  

Official title:

German Register of Outpatient Parenteral Antibiotic Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04413396
• Other study ID #: OPATReg
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2020
• Source: University of Cologne
• Contact: Clara Lehmann, Prof.
• Phone: +4922147839684
• Email: clara.lehmann[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who get OPAT

Exclusion Criteria:

• patients who don't get OPAT

Related Conditions & MeSH terms

• Implementation of OPAT in Germany

Intervention

Procedure:
• Outpatient Parenteral Antibiotic Therapy
Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with effective OPAT	Successful administration and completion of the antiinfective therapy	12 weeks
Primary	Number of Patients With Treatment-Related Adverse Events	side-effects of treatment and catheter-related infections	12 weeks
Primary	Number of Hospitals being able to apply OPAT	Feasibility of OPAT under differing hospital specific circumstances	12 weeks