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NCT Number: NCT07682389

Etiologic Diagnosis Algorithm in Infective Endocarditis

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

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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases Microbiology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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 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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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)

  4. Mortality

    Time frame: 30 days after diagnosis

    Probability of death within 30 days after diagnosis, estimated using the Kaplan-Meier method

Study contacts

Contact information is provided by the study sponsor or research team.

Svetlana Rachina, Professor

CONTACT

[email protected]

+7 910 715-89-55

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Collaborators

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

Registry information

Official study title

Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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