Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Informed consent,
• Age ≥ 18,
• IE (definite or possible per the 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis)
Locations
Other Locations
Russian Federation
A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health
NOT_YET_RECRUITING
Moscow
City Clinical Hospital Named After S. S. Yudin
RECRUITING
Moscow
City Clinical Hospital №67 Named After L. A. Vorokhobova
RECRUITING
Moscow
Contact Information
Primary
Svetlana Rachina, Professor
rachina_s_a@staff.sechenov.ru
+7 910 715-89-55
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2027-02-20
Participants
Target number of participants: 128
Treatments
Experimental: Comprehensive Etiological Diagnosis Group
Patients receive standard diagnostics plus molecular test results (PCR, PCR with sequencing) to guide etiotropic therapy
Active_comparator: Standard Clinical Practice Group
Patients receive standard care; molecular test results are blinded for the treating physician
Related Therapeutic Areas
Sponsors
Collaborators: Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor, City Clinical Hospital Named After S. S. Yudin, Moscow, Russian Federation, City Clinical Hospital №67 Named After L. A. Vorokhobova, Moscow, Russian Federation, A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health, Moscow, Russian Federation
Leads: I.M. Sechenov First Moscow State Medical University