Etiologic Diagnosis Algorithm in Infective Endocarditis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Molecular tests (PCR, sequencing), Standard Clinical Practice.
- Who it may be relevant to
- Registry conditions: Infective Endocarditis, Microbiology. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical Trial
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
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.
Interventions
- 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 - 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
Primary outcome measures
- Frequency of etiotropic antibiotic therapy prescription [Time frame: 14 days from the date of diagnosis]
Secondary outcome measures (4)
- IE Complications requiring surgical treatment [Time frame: At discharge (an average of 14 days)]
- Acute Kidney Injury [Time frame: At discharge (an average of 14 days)]
- ICU Transfer [Time frame: At discharge (an average of 14 days)]
- Mortality [Time frame: 30 days after diagnosis]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Russia · 3 centers
- A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Mi — Moscow
- City Clinical Hospital Named After S. S. Yudin — Moscow
- City Clinical Hospital №67 Named After L. A. Vorokhobova — Moscow
Identifiers
NCT: NCT07682389 · IE-2026