Etiologic Diagnosis Algorithm in Infective Endocarditis

NCT07682389 | Recruiting

• 1 other identifier: IE-2026
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Infective Endocarditis; Microbiology

Keywords

Infective endocarditis; PCR; Antibiotic therapy; Etiological diagnosis; Sequencing

Outcome Measures

Primary Outcomes (1)

• Frequency of etiotropic antibiotic therapy prescription

  Proportion of patients receiving specific ABT within 14 days of diagnosis

  14 days from the date of diagnosis

Secondary Outcomes (4)

• IE Complications requiring surgical treatment

  At discharge (an average of 14 days)

• Acute Kidney Injury

  At discharge (an average of 14 days)

• ICU Transfer

  At discharge (an average of 14 days)

• Mortality

  30 days after diagnosis

Study Arms (2)

Comprehensive Etiological Diagnosis Group

EXPERIMENTAL

Patients receive standard diagnostics plus molecular test results (PCR, PCR with sequencing) to guide etiotropic therapy

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

Diagnostic Test: Standard Clinical Practice

Interventions

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

Comprehensive Etiological Diagnosis Group

Standard Clinical Practice DIAGNOSTIC_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

Standard Clinical Practice Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent,
• Age ≥ 18,
• IE (definite or possible per the 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis)

You may not qualify if:

• 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).

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead
• Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor: collaborator
• City Clinical Hospital Named After S. S. Yudin, Moscow, Russian Federation: collaborator
• City Clinical Hospital №67 Named After L. A. Vorokhobova, Moscow, Russian Federation: collaborator
• A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health, Moscow, Russian Federation: collaborator

Study Sites (3)

A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health

Moscow, Russia

NOT YET RECRUITING

City Clinical Hospital Named After S. S. Yudin

Moscow, Russia

RECRUITING

City Clinical Hospital №67 Named After L. A. Vorokhobova

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Endocarditis

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Central Study Contacts

Svetlana Rachina, Professor

CONTACT

+7 910 715-89-55; rachina_s_a@staff.sechenov.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Molecular test results are blinded for the treating physician, and blinded endpoint assessment is implemented (PROBE, participant randomization group will be blinded for the Endpoint Committee)
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: July 2, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): February 4, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)