Infective EndocarditisNCT02388893
Endocarditis Registry of the University Hospital of Cologne (ER-UHC)
An observational study of Infective Endocarditis, run by University of Cologne at 1 site in Germany.
Trial summary
As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team including an cardiologist, infectious disease specialist, and cardiac surgeon. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Infective Endocarditis
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Dec 2022
- How long will I take part?
- 1 Year
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with definitive IE
Who may be able to join
- All patients with patients with definitive infective endocarditis
Who cannot join
- childs
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heart Center of the University of Cologne
Cologne, 50937
Guido Michels, Prof. Dr., ++49-221-478-32401, guido.michels@uk-koeln.de
About this study
As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team including an cardiologist, infectious disease specialist, and cardiac surgeon. Our registry is a prospective, national registry of patients with IE. From January 2013 data from endocarditis board were prospectively recorded using standard definitions during the hospitalization. Patient demographics, clinical, laboratory, and imaging data at the time of IE diagnosis, as well as treatment outcomes were entered into the ER-UHC database.
Read the detailed description
The primary endpoint will be the 1 year all-cause mortality after treatment begins of IE. We will use 1 year all-cause mortality as the primary endpoint because it has been demonstrated that a period of at least 6 months is necessary to offset the early postoperative mortality related to valve surgery. We also looked at all-cause in-hospital mortality as a secondary endpoint.
- Conditions
- Infective Endocarditis
- Medical subject headings
- Endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
1-year all-cause mortality
Measured: 1 year
Secondary outcomes (1)
Inhospital all-cause mortality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies 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
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Michels, University of Cologne
- Investigators
- Guido Michels, Prof. Dr., Principal investigator, Heart Center, University of Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388893
- Sponsor's protocol ID
- 14-221
- Other IDs
- 14-221
- Status last verified
- Oct 2018
- First submitted
- 9 Mar 2015
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocarditis Registry of the University Hospital of Cologne (ER-UHC)
- ClinicalTrials.gov ID
- NCT02388893
- Acronym / sponsor ID
- 14-221
- Conditions
- Infective Endocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- 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.
As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team including an cardiologist, infectious disease specialist, and cardiac surgeon. Our registry is a prospective, national registry of patients with IE. From January 2013 data from endocarditis board were prospectively recorded using standard definitions during the hospitalization. Patient demographics, clinical, laboratory, and imaging data at the time of IE diagnosis, as well as treatment outcomes were entered into the ER-UHC database.
Detailed description
The primary endpoint will be the 1 year all-cause mortality after treatment begins of IE. We will use 1 year all-cause mortality as the primary endpoint because it has been demonstrated that a period of at least 6 months is necessary to offset the early postoperative mortality related to valve surgery. We also looked at all-cause in-hospital mortality as a secondary endpoint.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with definitive IE
Key inclusion criteria (1 listed)
- All patients with patients with definitive infective endocarditis
Key exclusion criteria (1 listed)
- childs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 1 year
1-year all-cause mortality
1 secondary outcome
Inhospital all-cause mortality
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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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.
Guido Michels, Prof. Dr. principal investigator
Heart Center, University of Cologne, Germany
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 Infective Endocarditis, 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 17 Oct 2018. 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 Guido Michels, Prof. Dr. (++49-221-478-32401, guido.michels@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 1 year). 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 17 Oct 2018.