Clinical trial NCT04002453: Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne
Official title: Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Implementation of OPAT in Germany
Keywords: OPAT
infectious diseases
implementation
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic, university hospital

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.


Eligibility criteria: Inclusion Criteria:

* patients who get OPAT

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Patients with effective OPAT
timeFrame: 12 weeks
measure: Number of Patients With Treatment-Related Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
Study officials:
References:
citation: 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.