Etiologic Diagnosis Algorithm in Infective Endocarditis

June 28, 2026 updated by: I.M. Sechenov First Moscow State Medical University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
      • Moscow, Russia
        • Not yet recruiting
        • A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health
        • Contact:
          • Dmitry Popov, Prof
      • Moscow, Russia
        • Recruiting
        • City Clinical Hospital Named After S. S. Yudin
        • Contact:
      • Moscow, Russia
        • Recruiting
        • City Clinical Hospital №67 Named After L. A. Vorokhobova
        • Contact:
          • Svetlana Mirzakhamidova, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive Etiological Diagnosis Group
Patients receive standard diagnostics plus molecular test results (PCR, PCR with sequencing) to guide etiotropic therapy
Diagnostic test: 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
Active Comparator: Standard Clinical Practice Group
Patients receive standard care; molecular test results are blinded for the treating physician
Diagnostic test: Standard Clinical Practice
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days from the date of diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IE Complications requiring surgical treatment
Time Frame: At discharge (an average of 14 days)
Proportion of patients with IE-related complications (uncontrolled infection, heart failure, or embolic events) requiring surgical treatment during hospitalization
At discharge (an average of 14 days)
Acute Kidney Injury
Time Frame: At discharge (an average of 14 days)

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.
At discharge (an average of 14 days)
ICU Transfer
Time Frame: At discharge (an average of 14 days)
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)
At discharge (an average of 14 days)
Mortality
Time Frame: 30 days after diagnosis
Probability of death within 30 days after diagnosis, estimated using the Kaplan-Meier method
30 days after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

February 4, 2027

Study Completion (Estimated)

February 20, 2027

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 28, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IE-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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