Infective EndocarditisNCT07682389
Etiologic Diagnosis Algorithm in Infective Endocarditis
A study testing Molecular tests (PCR, sequencing) and Standard Clinical Practice in people with Infective Endocarditis and Microbiology, run by I.M. Sechenov First Moscow State Medical University at 3 sites in Russia.
Trial summary
The goal of this study is to evaluate the impact of a diagnostic algorithm combining culture-based and molecular methods on the frequency of etiotropic antibiotic therapy prescription within 14 days of diagnosis of infective endocarditis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis, Microbiology
- What is being tested?
- Molecular tests (PCR, sequencing) and Standard Clinical Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesRussia
- Study dates
- 20 Jan 2026to 20 Feb 2027
- Phase
- Interventional
- 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
Who may be able to join
- Informed consent,
- Age ≥ 18,
- IE (definite or possible per the 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis)
Who cannot join
- Pregnancy/breastfeeding
- Unconfirmed or rejected IE diagnosis,
- Very high risk of death within 14 days due to severe complications of the main or concomitant disease(s), according to the physician's opinion;
- Prior use of antibiotic therapy (except documented treatment failure).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia3 sites, 3 recruiting
- Not yet recruiting
A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health
Moscow
Dmitry Popov, Prof
- Recruiting
City Clinical Hospital Named After S. S. Yudin
Moscow
Svetlana Rachina, +7 910 715-89-55, rachina_s_a@staff.sechenov.ru
- Recruiting
City Clinical Hospital №67 Named After L. A. Vorokhobova
Moscow
Svetlana Mirzakhamidova, Dr
About this study
Official title: Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical Trial
The goal of this study is to evaluate the impact of a diagnostic algorithm combining culture-based and molecular methods on the frequency of etiotropic antibiotic therapy prescription within 14 days of diagnosis of infective endocarditis
Read the detailed description
This is an open-label (with blinded endpoint assessment) multicenter randomized trial designed to evaluate the impact of an etiological diagnostic algorithm incorporating various laboratory methods (culture-based and molecular) on the frequency of etiological antibiotic therapy prescription within 14 days after the diagnosis of infective endocarditis. While molecular samples are collected from all participants, results are only disclosed to physicians in the intervention group to guide treatment, while remaining blinded in the control group.
- Conditions
- Infective Endocarditis, Microbiology
- Being tested
- Molecular tests (PCR, sequencing), Standard Clinical Practice
- Keywords
- Infective endocarditis, PCR, Antibiotic therapy, Etiological diagnosis, Sequencing
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular tests (PCR, sequencing)Diagnostic test
PCR and PCR with consequent sequencing of the blood (or tissue) will be performed in addition to the cultural methods in the experimental study arm
Standard Clinical PracticeDiagnostic test
Patients receive standard care with analysis of microorganisms in at least 2 or more separate blood culture sets and from cardiac tissue (if surgical treatment is performed); molecular test results are blinded for the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Etiological Diagnosis Group | Experimental | Patients receive standard diagnostics plus molecular test results (PCR, PCR with sequencing) to guide etiotropic therapy Receives: Diagnostic Test: Molecular tests (PCR, sequencing) |
| Standard Clinical Practice Group | Active comparator | Patients receive standard care; molecular test results are blinded for the treating physician Receives: Diagnostic Test: Standard Clinical Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of etiotropic antibiotic therapy prescription
Proportion of patients receiving specific ABT within 14 days of diagnosis
Measured: 14 days from the date of diagnosis
Secondary outcomes (4)
IE Complications requiring surgical treatment
Proportion of patients with IE-related complications (uncontrolled infection, heart failure, or embolic events) requiring surgical treatment during hospitalization
Measured: At discharge (an average of 14 days)
Acute Kidney Injury
Proportion of patients with acute kidney injury during hospitalization, defined as:
increase in serum creatinine by ≥26.5 μmol/L within 48 hours, or increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days, or urine output <0.5 mL/kg/h for 6 hours.
Measured: At discharge (an average of 14 days)
ICU Transfer
Proportion of patients requiring transfer to the intensive care unit (ICU) during hospitalization (for admissions to non-ICU departments) or requiring repeated transfer to the ICU (if initially admitted to the ICU)
Measured: At discharge (an average of 14 days)
Mortality
Probability of death within 30 days after diagnosis, estimated using the Kaplan-Meier method
Measured: 30 days after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start20 Jan 2026
- Primary completion4 Feb 2027 (estimated)
- Study completion20 Feb 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor, City Clinical Hospital Named After S. S. Yudin, Moscow, Russian Federation, City Clinical Hospital №67 Named After L. A. Vorokhobova, Moscow, Russian Federation, A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health, Moscow, Russian Federation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682389
- Sponsor's protocol ID
- IE-2026
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data (IPD) because data protection requirements and consent procedures for this study do not allow external data sharing beyond the study team.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07682389
- Acronym / sponsor ID
- IE-2026
- Conditions
- Infective Endocarditis, Microbiology
- Keywords
- Infective endocarditis, PCR, Antibiotic therapy, Etiological diagnosis, Sequencing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Collaborators
- Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor, City Clinical Hospital Named After S. S. Yudin, Moscow, Russian Federation, City Clinical Hospital №67 Named After L. A. Vorokhobova, Moscow, Russian Federation, A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health, Moscow, Russian Federation
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 4 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 2 Jul 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.
The goal of this study is to evaluate the impact of a diagnostic algorithm combining culture-based and molecular methods on the frequency of etiotropic antibiotic therapy prescription within 14 days of diagnosis of infective endocarditis
Detailed description
This is an open-label (with blinded endpoint assessment) multicenter randomized trial designed to evaluate the impact of an etiological diagnostic algorithm incorporating various laboratory methods (culture-based and molecular) on the frequency of etiological antibiotic therapy prescription within 14 days after the diagnosis of infective endocarditis. While molecular samples are collected from all participants, results are only disclosed to physicians in the intervention group to guide treatment, while remaining blinded in the control group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Etiological Diagnosis Group | Experimental | Diagnostic Test: Molecular tests (PCR, sequencing)Patients receive standard diagnostics plus molecular test results (PCR, PCR with sequencing) to guide etiotropic therapy |
| Standard Clinical Practice Group | Active comparator | Diagnostic Test: Standard Clinical PracticePatients receive standard care; molecular test results are blinded for the treating physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent,
- Age ≥ 18,
- IE (definite or possible per the 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis)
Key exclusion criteria (4 listed)
- Pregnancy/breastfeeding
- Unconfirmed or rejected IE diagnosis,
- Very high risk of death within 14 days due to severe complications of the main or concomitant disease(s), according to the physician's opinion;
- Prior use of antibiotic therapy (except documented treatment failure).
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 |
|---|---|---|
| Molecular tests (PCR, sequencing)PCR and PCR with consequent sequencing of the blood (or tissue) will be performed in addition to the cultural methods in the experimental study arm | Diagnostic test | Comprehensive Etiological Diagnosis Group |
| Standard Clinical PracticePatients receive standard care with analysis of microorganisms in at least 2 or more separate blood culture sets and from cardiac tissue (if surgical treatment is performed); molecular test results are blinded for the treating physician | Diagnostic test | Standard Clinical Practice Group |
Primary outcome
Frequency of etiotropic antibiotic therapy prescription
Time frame: 14 days from the date of diagnosis
Proportion of patients receiving specific ABT within 14 days of diagnosis
4 secondary outcomes
IE Complications requiring surgical treatment
Time frame: At discharge (an average of 14 days)
Acute Kidney Injury
Time frame: At discharge (an average of 14 days)
ICU Transfer
Time frame: At discharge (an average of 14 days)
Mortality
Time frame: 30 days after diagnosis
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 2 Jul 2026.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data (IPD) because data protection requirements and consent procedures for this study do not allow external data sharing beyond the study team.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular tests (PCR, sequencing) and Standard Clinical Practice in people with Infective Endocarditis and Microbiology, run by I.M. Sechenov First Moscow State Medical University at 3 sites in Russia.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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?
Contact Svetlana Rachina, Professor (+7 910 715-89-55, rachina_s_a@staff.sechenov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of etiotropic antibiotic therapy prescription (time frame: 14 days from the date of diagnosis). 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 2 Jul 2026.