Infective Endocarditis (IE)ERGOSTENCT07108803
European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis
An observational study of Infective Endocarditis (IE), run by Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) at 1 site in Italy.
Trial summary
The European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE) is a nascent large surgical registry that would encompass most relevant aspects of IE in Europe in the contemporary era. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis (IE)
- How many people
- 2,500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients undergoing cardiac surgery due to infective endocarditis
Who may be able to join
- Patients undergoing cardiac surgery due to infective endocarditis
Who cannot join
- Patients under 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE)
The European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE) is a nascent large surgical registry that would encompass most relevant aspects of IE in Europe in the contemporary era.
Read the detailed description
ERGOSTE, Purposes:
- To create a European multicenter retrospective database including a large number of patients undergoing surgical treatment for infective endocarditis (IE).
- To perform epidemiologic analyses of IE-patients and involved pathogens.
- To find independent predictors of early post-operative death.
- To test ALL the scoring systems specifically developed to predict early death after surgery for infective endocarditis.
- To devise a specific risk score for early postoperative death.
- To explore early and late outcomes of these very difficult patients in order to establish optimal indications, techniques and timing of surgery.
- To carry out a number of sub-analyses concerning the demographic parameters and variable clinical presentation of patients, type and severity of cardiac structural involvement, adopted valve prostheses and surgical techniques, and different involved microbiologic agents.
- To lay experiential foundations of a prospective database on the topic.
- Conditions
- Infective Endocarditis (IE)
- Keywords
- Infective endocarditis, Cardiac surgery, Outcomes, Risk score, Prediction, In-hospital mortality, Pathogen agents, Statistics, Sepsis, Surgical techniques, Epidemiology
- Medical subject headings
- Endocarditis, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Early post-operative mortality
Measured: Mortality at 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Jun 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective Endocarditis (IE)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Gatti, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108803
- Sponsor's protocol ID
- 386_2024
- Acronym
- ERGOSTE
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE)
- ClinicalTrials.gov ID
- NCT07108803
- Acronym / sponsor ID
- ERGOSTE / 386_2024
- Conditions
- Infective Endocarditis (IE)
- Keywords
- Infective endocarditis, Cardiac surgery, Outcomes, Risk score, Prediction, In-hospital mortality, Pathogen agents, Statistics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)University, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 7 Aug 2025 (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.
The European Research Group on Outcomes of Surgical Treatment of Infective Endocarditis (ERGOSTE) is a nascent large surgical registry that would encompass most relevant aspects of IE in Europe in the contemporary era.
Detailed description
ERGOSTE, Purposes:
- To create a European multicenter retrospective database including a large number of patients undergoing surgical treatment for infective endocarditis (IE).
- To perform epidemiologic analyses of IE-patients and involved pathogens.
- To find independent predictors of early post-operative death.
- To test ALL the scoring systems specifically developed to predict early death after surgery for infective endocarditis.
- To devise a specific risk score for early postoperative death.
- To explore early and late outcomes of these very difficult patients in order to establish optimal indications, techniques and timing of surgery.
- To carry out a number of sub-analyses concerning the demographic parameters and variable clinical presentation of patients, type and severity of cardiac structural involvement, adopted valve prostheses and surgical techniques, and different involved microbiologic agents.
- To lay experiential foundations of a prospective database on the topic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery due to infective endocarditis
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery due to infective endocarditis
Key exclusion criteria (1 listed)
- Patients under 18 years
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
Early post-operative mortality
Time frame: Mortality at 1 year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Yes
Related trials for Infective Endocarditis (IE)
Not yet recruiting
Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
From Commensalism to Pathogenicity: Exploring the Pathophysiology of Bacteremia to Better Understand Enterococcus Faecalis Infective Endocarditis
Infective Endocarditis (IE)
Active, not recruitingObservational study
Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft
Infective Endocarditis, Heart Failure
Active, not recruitingObservational study
Long Term Management and Outcomes of Surgical and Non Surgical Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
Reducing Risk for Infective Endocarditis
Bacteremia, Infective Endocarditis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 (IE), run by Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) at 1 site in Italy.
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: enrolling by invitation, as of the sponsor's last update on 7 Aug 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early post-operative mortality (time frame: Mortality at 1 year after surgery). 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 7 Aug 2025.