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| Name | Class |
|---|---|
| Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor | UNKNOWN |
| City Clinical Hospital Named After S. S. Yudin, Moscow, Russian Federation | UNKNOWN |
| City Clinical Hospital №67 Named After L. A. Vorokhobova, Moscow, Russian Federation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comprehensive Etiological Diagnosis Group | Experimental | Patients receive standard diagnostics plus molecular test results (PCR, PCR with sequencing) to guide etiotropic therapy |
|
| Standard Clinical Practice Group | Active Comparator | Patients receive standard care; molecular test results are blinded for the treating physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of etiotropic antibiotic therapy prescription | Proportion of patients receiving specific ABT within 14 days of diagnosis | 14 days from the date of diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| IE Complications requiring surgical treatment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Svetlana Rachina, Professor | Contact | +7 910 715-89-55 | rachina_s_a@staff.sechenov.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health | Not yet recruiting | Moscow | Russia |
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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| ID | Term |
|---|---|
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001483 | Base Sequence |
| ID | Term |
|---|---|
| D015394 | Molecular Structure |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D040342 | Genetic Structures |
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| UNKNOWN |
| A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health, Moscow, Russian Federation | UNKNOWN |
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Molecular test results are blinded for the treating physician, and blinded endpoint assessment is implemented (PROBE, participant randomization group will be blinded for the Endpoint Committee)
| 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 |
|
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 | 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 | Probability of death within 30 days after diagnosis, estimated using the Kaplan-Meier method | 30 days after diagnosis |
| City Clinical Hospital Named After S. S. Yudin | Recruiting | Moscow | Russia |
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| City Clinical Hospital №67 Named After L. A. Vorokhobova | Recruiting | Moscow | Russia |
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| D055614 |
| Genetic Phenomena |