Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04002453
Other study ID # C-OPAT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date June 30, 2023

Study information

Verified date September 2022
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients who get OPAT Exclusion Criteria: - patients who don't get OPAT or are not capable to give their informed consent

Study Design


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 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-effetcs of treatment and catheter-related infections 12 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04413396 - German Register of Outpatient Parenteral Antibiotic Therapy