Implementation of OPAT in GermanyOPATRegNCT04413396
German Register of Outpatient Parenteral Antibiotic Therapy
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
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 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
- Adult, Older adult
Study population: Adults getting OPAT in one of the participating study sites
Who may be able to join
- patients who get OPAT
Who cannot join
- patients who don't get OPAT
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, 50937
Clara Lehmann, Prof., clara.lehmann@uk-koeln.de
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 aim of OPATReg is to examine under which conditions the OPAT can be established at different locations of patient care. For this purpose, patients with APAT are to be treated and data collected at 7 university institutions in Germany. All centers have the expertise to provide comprehensive care for patients with infectious diseases, to transfer them from inpatient to outpatient care and to continue to provide care there.
If successful, the project should help to identify the potential of OPAT for all of Germany. If positive effects and feasibility can be demonstrated 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
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-effects of treatment and catheter-related infections
Measured: 12 weeks
Number of Hospitals being able to apply OPAT
Feasibility of OPAT under differing hospital specific circumstances
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 posted2 Jun 2020
- Study start1 Oct 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 600 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
- Investigators
- Clara Lehmann, Prof., Study chair, Head of Outpatient Department in ID, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413396
- Sponsor's protocol ID
- OPATReg
- Acronym
- OPATReg
- Status last verified
- Nov 2020
- First submitted
- 28 May 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Register of Outpatient Parenteral Antibiotic Therapy
- ClinicalTrials.gov ID
- NCT04413396
- Acronym / sponsor ID
- OPATReg / OPATReg
- Conditions
- Implementation of OPAT in Germany
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Jun 2020 (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 aim of OPATReg is to examine under which conditions the OPAT can be established at different locations of patient care. For this purpose, patients with APAT are to be treated and data collected at 7 university institutions in Germany. All centers have the expertise to provide comprehensive care for patients with infectious diseases, to transfer them from inpatient to outpatient care and to continue to provide care there.
If successful, the project should help to identify the potential of OPAT for all of Germany. If positive effects and feasibility can be demonstrated 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
- Age groups
- Adult, Older adult
- Study population
- Adults getting OPAT in one of the participating study sites
Key inclusion criteria (1 listed)
- patients who get OPAT
Key exclusion criteria (1 listed)
- patients who don't get OPAT
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-effects of treatment and catheter-related infections
Number of Hospitals being able to apply OPAT
Time frame: 12 weeks
Feasibility of OPAT under differing hospital specific circumstances
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- 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.
Clara Lehmann, Prof. study chair
Head of Outpatient Department in ID, University Hospital of Cologne
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 5 Nov 2020. 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?
Contact Clara Lehmann, Prof. (+4922147839684, clara.lehmann@uk-koeln.de), or a site near the patient. 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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2020.