Etiologic Diagnosis Algorithm in Infective Endocarditis

I.M. Sechenov First Moscow State Medical University128 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

128

Conditions

Infective Endocarditis Microbiology

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (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

Outcomes

Primary Outcomes

Frequency of etiotropic antibiotic therapy prescription

Proportion of patients receiving specific ABT within 14 days of diagnosis

Time frame: 14 days from the date of diagnosis

Secondary Outcomes

IE Complications requiring surgical treatment

Proportion of patients with IE-related complications (uncontrolled infection, heart failure, or embolic events) requiring surgical treatment during hospitalization

Time frame: 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.

Time frame: 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)

Time frame: At discharge (an average of 14 days)

Mortality

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

Time frame: 30 days after diagnosis

Central Contacts

Svetlana Rachina, Professor

CONTACT

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

Data from ClinicalTrials.gov

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