Implementation of OPAT in GermanyNCT04002453
Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne
An observational study of Implementation of OPAT in Germany, run by University of Cologne at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implementation of OPAT in Germany
- What is being tested?
- Outpatient Parenteral Antibiotic Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2020to 30 Jun 2023
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic, university hospital
Who may be able to join
- patients who get OPAT
Who cannot join
- patients who don't get OPAT or are not capable to give their informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Cologne
Cologne, 50937
Clara Lehmann, MD, +4922147888835, clara.lehmann@uk-koeln.de
Lehmann Clara, MD
About this study
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.
Read more
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
- Being tested
- Outpatient Parenteral Antibiotic Therapy
- Keywords
- OPAT, infectious diseases, implementation
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Parenteral Antibiotic TherapyProcedure or surgery
Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient parenteral antimicrobial therapy | Patients with an infectious disease that receive an outpatient parenteral antimicrobial therapy Receives: Procedure: Outpatient Parenteral Antibiotic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with effective OPAT
Successful administration and completion of the antiinfective therapy
Measured: 12 weeks
Number of Patients With Treatment-Related Adverse Events
side-effetcs of treatment and catheter-related infections
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Implementation of OPAT in GermanyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Lehmann, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002453
- Sponsor's protocol ID
- C-OPAT
- Status last verified
- Sep 2022
- First submitted
- 21 Jun 2019
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38685017Schmidt-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.
PubMed 38478255Scholten 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.
PubMed 36375971
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Parenteral Antibiotic Therapy in the Metropolitan Area of Cologne
- ClinicalTrials.gov ID
- NCT04002453
- Acronym / sponsor ID
- C-OPAT
- Conditions
- Implementation of OPAT in Germany
- Keywords
- OPAT, infectious diseases, implementation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient parenteral antimicrobial therapy | – | Procedure: Outpatient Parenteral Antibiotic TherapyPatients with an infectious disease that receive an outpatient parenteral antimicrobial therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic, university hospital
Key inclusion criteria (1 listed)
- patients who get OPAT
Key exclusion criteria (1 listed)
- patients who don't get OPAT or are not capable to give their informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient Parenteral Antibiotic TherapyApplication of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital. | Procedure or surgery | Outpatient parenteral antimicrobial therapy |
Primary outcome
Number of Patients with effective OPAT
Time frame: 12 weeks
Successful administration and completion of the antiinfective therapy
Number of Patients With Treatment-Related Adverse Events
Time frame: 12 weeks
side-effetcs of treatment and catheter-related infections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Derived from this study: PubMed 38685017Peter 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.
- Derived from this study: PubMed 38478255Schmidt-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.
- Derived from this study: PubMed 36375971Scholten 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implementation of OPAT in Germany, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with effective OPAT (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04002453, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.