Etiologic Diagnosis Algorithm in Infective Endocarditis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorI.M. Sechenov First Moscow State Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Informed consent,
Age ≥ 18,
IE (definite or possible per the 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis)
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Molecular tests (PCR, sequencing)
Diagnostic testPCR 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 Practice
Diagnostic testPatients 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
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Comprehensive Etiological Diagnosis GroupExperimental treatment 1 intervention
Group B: Standard Clinical Practice GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 diagnosisSecondary outcomes
1
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)2
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)3
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)4
Mortality
Probability of death within 30 days after diagnosis, estimated using the Kaplan-Meier method
Time frame
30 days after diagnosisSponsors and contacts
Click on the lead sponsor to view all of their trials.
I.M. Sechenov First Moscow State Medical University
Lead sponsor
Federal State Budgetary Institution of the Central Research Institute of Epidemiology of Rospotrebnadzor
Collaborator
City Clinical Hospital Named After S. S. Yudin, Moscow, Russian Federation
Collaborator
City Clinical Hospital №67 Named After L. A. Vorokhobova, Moscow, Russian Federation
Collaborator
A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health, Moscow, Russian Federation
Collaborator
Source ClinicalTrials.gov