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Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne

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ClinicalTrials.gov Identifier: NCT04002453
Recruitment Status : Not yet recruiting
First Posted : June 28, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Clara Lehmann, University of Cologne

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.


Condition or disease Intervention/treatment
Implementation of OPAT in Germany Procedure: Outpatient Parenteral Antibiotic Therapy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Weeks
Official Title: Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.




Primary Outcome Measures :
  1. Number of Patients with effective OPAT [ Time Frame: 12 weeks ]
    Successful administration and completion of the antiinfective therapy

  2. Number of Patients With Treatment-Related Adverse Events [ Time Frame: 12 weeks ]
    side-effetcs of treatment and catheter-related infections



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
primary care clinic, university hospital
Criteria

Inclusion Criteria:

  • patients who get OPAT

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002453


Locations
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Germany
University of Cologne
Cologne, Germany, 50937
Sponsors and Collaborators
University of Cologne

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Responsible Party: Clara Lehmann, Head of outpatient clinic, University of Cologne
ClinicalTrials.gov Identifier: NCT04002453     History of Changes
Other Study ID Numbers: C-OPAT
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clara Lehmann, University of Cologne:
OPAT
infectious diseases
implementation

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents