Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne

NCT ID: NCT04002453

Last Updated: 2022-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Implementation of OPAT in Germany

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Outpatient parenteral antimicrobial therapy

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

Outpatient Parenteral Antibiotic Therapy

Intervention Type PROCEDURE

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

Interventions

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Outpatient Parenteral Antibiotic Therapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients who get OPAT

Exclusion Criteria

* patients who don't get OPAT or are not capable to give their informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Clara Lehmann

Head of outpatient clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Cologne

Cologne, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Clara Lehmann, MD

Role: primary

+4922147888835

References

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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.

Reference Type DERIVED
PMID: 38685017 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38478255 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36375971 (View on PubMed)

Other Identifiers

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C-OPAT

Identifier Type: -

Identifier Source: org_study_id

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