An interventional study of Molecular tests (PCR, sequencing) and Standard Clinical Practice in Infective Endocarditis and Microbiology, sponsored by I.M. Sechenov First Moscow State Medical University. Recruiting at 3 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Diagnostic
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 128 is above the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive standard diagnostics plus molecular test results (PCR, PCR with sequencing) to guide etiotropic therapy
Diagnostic Test: Molecular tests (PCR, sequencing)
Patients receive standard care; molecular test results are blinded for the treating physician
Diagnostic Test: Standard Clinical Practice
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
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
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
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
Plan to share: No — 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.
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