Etiologic Diagnosis Algorithm in Infective Endocarditis

Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical 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

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.

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).