Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne

NCT04002453 | Unknown

• 1 other identifier: C-OPAT
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Implementation of OPAT in Germany

Keywords

OPAT; infectious diseases; implementation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Outpatient parenteral antimicrobial therapy

Patients with an infectious disease that receive an outpatient parenteral antimicrobial therapy

Procedure: Outpatient Parenteral Antibiotic Therapy

Interventions

Outpatient Parenteral Antibiotic Therapy PROCEDURE

Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.

Outpatient parenteral antimicrobial therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic, university hospital

You may qualify if:

• patients who get OPAT

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University of Cologne

Cologne, 50937, Germany

RECRUITING

Related Publications (3)

• Peter S, Oberrohrmann C, Pfaff H, Lehmann C, Schmidt-Hellerau K, Brandes V, Leisse C, Lindemann CH, Ihle P, Kupper-Nybelen J, Hagemeier A, Scholten N. Exploring patients' perspectives: a mixed methods study on Outpatient Parenteral Antimicrobial Therapy (OPAT) experiences. BMC Health Serv Res. 2024 Apr 29;24(1):544. doi: 10.1186/s12913-024-11017-9.

  PMID: 38685017 DERIVED

• Schmidt-Hellerau K, Baade N, Gunther M, Scholten N, Lindemann CH, Leisse C, Oberrohrmann C, Peter S, Jung N, Suarez I, Horn C, Ihle P, Kupper-Nybelen J, Hagemeier A, Hellmich M, Lehmann C. Outpatient parenteral antimicrobial therapy (OPAT) in Germany: insights and clinical outcomes from the K-APAT cohort study. Infection. 2024 Aug;52(4):1407-1414. doi: 10.1007/s15010-024-02199-9. Epub 2024 Mar 13.

  PMID: 38478255 DERIVED

• 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.

  PMID: 36375971 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of outpatient clinic

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 28, 2019
• Study Start: July 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

DE (1)