Etiologic Diagnosis Algorithm in Infective Endocarditis
Official title: Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical Trial
Run by I.M. Sechenov First Moscow State Medical University · NCT07682389 · Data updated 2026-11-12
Aiming to see if a combined culture and molecular testing approach can help doctors choose the right antibiotics faster for adults with infective endocarditis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | I.M. Sechenov First Moscow State Medical University Academic / other |
| Locations | 3 sites (Moscow and 2 other locations) |
| Status | Recruiting |
| Started | January 20, 2026 |
| Main results expected | February 4, 2027 |
| Study ends | February 20, 2027 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07682389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with definite or possible infective endocarditis per 2023 Duke-ISHC criteria, who have given informed consent.
✕Probably not a fit
Patients with very high risk of death within 14 days or those who have already started antibiotic therapy before enrollment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label trial tests whether an etiological diagnostic algorithm that includes culture-based methods and molecular tests can increase the use of etiotropic antibiotics within 14 days of diagnosing infective endocarditis. Results are shared with clinicians in the intervention group to guide treatment, while the control group remains blinded to molecular results. The study enrolls adults with definite or possible infective endocarditis and compares the antibiotic decision-making between groups.
Why it matters
Potential benefit: If successful, patients may receive more targeted antibiotics sooner, potentially improving outcomes.
How similar studies have gone: Previous studies using integrated culture and molecular methods have shown promise in guiding therapy, but this trial adds a blinded-control design to assess impact.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent, * Age ≥ 18, * IE (definite or possible per the 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis) Exclusion Criteria: * 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).
Where it's running
-
City Clinical Hospital Named After S. S. Yudin
Moscow, Russia Recruiting -
City Clinical Hospital №67 Named After L. A. Vorokhobova
Moscow, Russia Recruiting -
A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health
Moscow, Russia Not yet recruiting
Study contacts
- Study coordinator: Svetlana Rachina, Professor
- Email: rachina_s_a@staff.sechenov.ru
- Phone: +7 910 715-89-55
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.