Infective Endocarditis (IE)ENDOCARDITISNCT07825272
Long Term Management and Outcomes of Surgical and Non Surgical Infective Endocarditis
An observational study of Infective Endocarditis (IE), run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
Infective endocarditis (IE) is a complex clinical condition in which approximately half of patients require surgical treatment during hospitalization, while the remaining patients are managed medically according to current guideline recommendations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis (IE)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,046 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 30 Jan 2030
- 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: The study will enroll approximately 1,046 patients with definite infective endocarditis across participating centers, including both retrospective and prospective cohorts. The retrospective cohort will include patients diagnosed from 2021 onward with available clinical and follow-up data. The prospective cohort will consist of consecutive patients enrolled during the study period according to routine clinical practice. Both cohorts will include patients managed surgically and patients managed with medical therapy alone. All patients will be treated according to standard clinical practice, with no additional interventions required for study participation.
Who may be able to join
- All patients with definite diagnosis of endocarditis based on the modified Duke Criteria including surgical findings
- Age over 18 years old
Who cannot join
- Exclusion criteria are cases of unconfirmed endocarditis and patients with endocarditis of PM/CIED
- Patients who refuse to receive clinical follow up
- Unable to give Informed Consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ENDOCARDITIS: Long Term Management and Outcomes of Surgical and Non Surgical Infective Endocarditis
Infective endocarditis (IE) is a complex clinical condition in which approximately half of patients require surgical treatment during hospitalization, while the remaining patients are managed medically according to current guideline recommendations. However, limited evidence is available regarding the long-term management and outcomes of patients treated conservatively after completion of antibiotic therapy.
The ENDOCARDITIS study is a multicenter, observational study with retrospective and prospective components designed to evaluate long-term outcomes in patients with definite infective endocarditis managed either surgically or with medical therapy alone. Adult patients will be enrolled and followed for up to 24 months. The primary objective is to compare long-term outcomes between surgical and non-surgical patients, while the secondary objective is to define optimal long-term follow-up strategies for patients treated medically.
Read the detailed description
Infective Endocarditis (IE) is a complex condition and not all patients require surgery. According to update guidelines, approximaly 50% of patients with IE require surgery during hospitalisation. The remaining 50% of patients are treated with medical therapy. ESC guidelines (2023) are very clear in defining the indication and timing of surgery in patients with IE: heart failure, risk of embolism and uncontrolled infection are clear indications for surgery in a short timeframe but, the decision making, should take into account not only the localisation and the extension of the infection, but also patient' s pre operative status and his comorbidities, as well as the mind status. In addition to patients excluded from surgery due to status and comorbidities, there is also a share of patients who do not meet the criteria for surgery. These patients can be treated with adequate IV antibiotic therapy and then with oral therapy.
- Conditions
- Infective Endocarditis (IE)
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | For the retrospective component of the study, medical records of patients diagnosed with definite infective endocarditis from 2021 onwards will be reviewed. Clinical data, microbiological findings, imaging data, therapeutic management (including antibiotic ther apy and surgical procedures), and follow up information will be collected retrospectively from hospital databases and electronic medical records. Patients included in the retrospective cohort will have an available clinical follow up of approximately 24 m onths between January 2021 and January 2025 | |
| Prospective Cohort | Prospective observational study enrolling consecutive adult patients with definite infective endocarditis managed according to routine clinical practice. Data are collected at baseline, at end of antibiotic therapy and/or switch from intravenous to oral therapy, and at 6, 12, and 24 months follow-up. Variables include demographics, microbiological findings, imaging (TTE, TEE, CT, PET when clinically indicated), surgical interventions, and antibiotic treatments. Patients are categorized into surgical (cardiac surgery) and non-surgical cohorts; the non-surgical cohort is further stratified into patients not undergoing surgery due to comorbidities/high surgical risk and patients not undergoing surgery due to favorable response to antibiotic therapy. Follow-up assessments include clinical evaluation and echocardiography per standard care. No additional procedures, interventions, or visits beyond routine clinical practice are required. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Clinical Events (MACE) During Follow-up
Proportion of participants experiencing at least one major adverse clinical event, defined as all-cause mortality, recurrent infective endocarditis (relapse or reinfection), hospitalization, systemic embolic event, or heart failure during follow-up. Events will be assessed through clinical evaluation and review of medical records.
Measured: Baseline through 24-month follow-up
Secondary outcomes (3)
All-Cause Mortality During 24-Month Follow-up
Proportion of patients experiencing all-cause mortality during follow-up.
Measured: Baseline through 24-month follow-up
Relapse or Reinfection of Infective Endocarditis During 24-Month Follow-up
Proportion of patients experiencing relapse or reinfection of infective endocarditis during follow-up.
Measured: Baseline through 24-month follow-up
Hospitalization During 24-Month Follow-up
Proportion of patients experiencing hospitalization during follow-up
Measured: Baseline through 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jun 2026
- Primary completion30 Jan 2030 (estimated)
- Study completion30 Jan 2030 (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
- Other
- Enrolment
- 1,046 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Clinico Humanitas, ASST Grande Ospedale Metropolitano Niguarda, Germans Trias i Pujol Hospital, Hospital Universitari Vall d'Hebron Research Institute, UMC Utrecht, Leiden University Medical Center, Helsinki University Central Hospital
- Responsible party
- Sponsor
- Investigators
- Gianluca Pontone, MD, Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825272
- Sponsor's protocol ID
- L2-617
- Acronym
- ENDOCARDITIS
- Status last verified
- May 2026
- First submitted
- 15 Jul 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOCARDITIS: Long Term Management and Outcomes of Surgical and Non Surgical Infective Endocarditis
- ClinicalTrials.gov ID
- NCT07825272
- Acronym / sponsor ID
- ENDOCARDITIS / L2-617
- Conditions
- Infective Endocarditis (IE)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,046 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Istituto Clinico Humanitas, ASST Grande Ospedale Metropolitano Niguarda, Germans Trias i Pujol Hospital, Hospital Universitari Vall d'Hebron Research Institute, UMC Utrecht, Leiden University Medical Center, Helsinki University Central Hospital
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jan 2030 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 17 Sep 2026 (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.
Infective endocarditis (IE) is a complex clinical condition in which approximately half of patients require surgical treatment during hospitalization, while the remaining patients are managed medically according to current guideline recommendations. However, limited evidence is available regarding the long-term management and outcomes of patients treated conservatively after completion of antibiotic therapy.
The ENDOCARDITIS study is a multicenter, observational study with retrospective and prospective components designed to evaluate long-term outcomes in patients with definite infective endocarditis managed either surgically or with medical therapy alone. Adult patients will be enrolled and followed for up to 24 months. The primary objective is to compare long-term outcomes between surgical and non-surgical patients, while the secondary objective is to define optimal long-term follow-up strategies for patients treated medically.
Detailed description
Infective Endocarditis (IE) is a complex condition and not all patients require surgery. According to update guidelines, approximaly 50% of patients with IE require surgery during hospitalisation. The remaining 50% of patients are treated with medical therapy. ESC guidelines (2023) are very clear in defining the indication and timing of surgery in patients with IE: heart failure, risk of embolism and uncontrolled infection are clear indications for surgery in a short timeframe but, the decision making, should take into account not only the localisation and the extension of the infection, but also patient' s pre operative status and his comorbidities, as well as the mind status. In addition to patients excluded from surgery due to status and comorbidities, there is also a share of patients who do not meet the criteria for surgery. These patients can be treated with adequate IV antibiotic therapy and then with oral therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | –For the retrospective component of the study, medical records of patients diagnosed with definite infective endocarditis from 2021 onwards will be reviewed. Clinical data, microbiological findings, imaging data, therapeutic management (including antibiotic ther apy and surgical procedures), and follow up information will be collected retrospectively from hospital databases and electronic medical records. Patients included in the retrospective cohort will have an available clinical follow up of approximately 24 m onths between January 2021 and January 2025 |
| Prospective Cohort | – | –Prospective observational study enrolling consecutive adult patients with definite infective endocarditis managed according to routine clinical practice. Data are collected at baseline, at end of antibiotic therapy and/or switch from intravenous to oral therapy, and at 6, 12, and 24 months follow-up. Variables include demographics, microbiological findings, imaging (TTE, TEE, CT, PET when clinically indicated), surgical interventions, and antibiotic treatments. Patients are categorized into surgical (cardiac surgery) and non-surgical cohorts; the non-surgical cohort is further stratified into patients not undergoing surgery due to comorbidities/high surgical risk and patients not undergoing surgery due to favorable response to antibiotic therapy. Follow-up assessments include clinical evaluation and echocardiography per standard care. No additional procedures, interventions, or visits beyond routine clinical practice are required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll approximately 1,046 patients with definite infective endocarditis across participating centers, including both retrospective and prospective cohorts. The retrospective cohort will include patients diagnosed from 2021 onward with available clinical and follow-up data. The prospective cohort will consist of consecutive patients enrolled during the study period according to routine clinical practice. Both cohorts will include patients managed surgically and patients managed with medical therapy alone. All patients will be treated according to standard clinical practice, with no additional interventions required for study participation.
Key inclusion criteria (2 listed)
- All patients with definite diagnosis of endocarditis based on the modified Duke Criteria including surgical findings
- Age over 18 years old
Key exclusion criteria (3 listed)
- Exclusion criteria are cases of unconfirmed endocarditis and patients with endocarditis of PM/CIED
- Patients who refuse to receive clinical follow up
- Unable to give 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.
Primary outcome
Incidence of Major Adverse Clinical Events (MACE) During Follow-up
Time frame: Baseline through 24-month follow-up
Proportion of participants experiencing at least one major adverse clinical event, defined as all-cause mortality, recurrent infective endocarditis (relapse or reinfection), hospitalization, systemic embolic event, or heart failure during follow-up. Events will be assessed through clinical evaluation and review of medical records.
3 secondary outcomes
All-Cause Mortality During 24-Month Follow-up
Time frame: Baseline through 24-month follow-up
Relapse or Reinfection of Infective Endocarditis During 24-Month Follow-up
Time frame: Baseline through 24-month follow-up
Hospitalization During 24-Month Follow-up
Time frame: Baseline through 24-month follow-up
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 17 Sep 2026.
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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.
Gianluca Pontone, MD principal investigator
Centro Cardiologico Monzino
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 Centro Cardiologico Monzino 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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. 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?
Incidence of Major Adverse Clinical Events (MACE) During Follow-up (time frame: Baseline through 24-month follow-up). 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 Sep 2026.