Infective Endocarditis, Microbiology
Conditions
Keywords
Infective endocarditis, PCR, Antibiotic therapy, Etiological diagnosis, Sequencing
Brief 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
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_TESTMolecular 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_TESTStandard 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
Sponsors
I.M. Sechenov First Moscow State Medical University
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of etiotropic antibiotic therapy prescription | 14 days from the date of diagnosis | Proportion of patients receiving specific ABT within 14 days of diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IE Complications requiring surgical treatment | At discharge (an average of 14 days) | Proportion of patients with IE-related complications (uncontrolled infection, heart failure, or embolic events) requiring surgical treatment during hospitalization |
| Acute Kidney Injury | At discharge (an average of 14 days) | 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. |
| ICU Transfer | At discharge (an average of 14 days) | 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) |
| Mortality | 30 days after diagnosis | Probability of death within 30 days after diagnosis, estimated using the Kaplan-Meier method |
Countries
Russia
Contacts
CONTACTSvetlana Rachina, Professor
Outcome results
None listed