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Life sciences · Interventional Study
ClinicalTrials.gov · November 4, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07917325). This is a study registration, not published results. Lead sponsor: University Hospital, Angers. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 240 participants (ESTIMATED). Conditions: Infective Endocarditis (IE). Interventions: PROCEDURE: Blood sample. Primary outcome measures: Metabolomic signature , Day 1 and Day 5 after enrollement. Brief summary: Most cases of Infective endocarditis (IE) are caused by Gram-positive bacteria, primarily Staphylococcus aureus, oral or intestinal streptococci, and enterococci (especially Enterococcus faecalis). Blood cultures for these bacteria may indicate simple bacteremia (without cardiac involvement) or endocarditis. The proportion of patients with IE among those presenting with positive blood cultures varies depending on the pathogen (approximately 10% for S. aureus, 5 to 50% for oral streptococci, depending on the species, and 15% for E. faecalis). The PPSIE study aims to identify a specific biological signature of infective endocarditis that would allow identification of valvular involvement in patients with positive blood cultures. Patients will be selected based on a blood culture positive for one of the following organisms: S. aureus, S. mutans, S. gordonii, S. sanguinis, S. parasanguinis, S. gallolyticus, S. mitis/oralis, E. faecalis, as well as based on the likelihood of endocarditis determined by a clinical score specific to the causative pathogen (VIRSTA, HANDOC, or DENOVA) A blood sample will be collected 1 day, 5 days, and 3 months after enrollment. Patients will be classified into the groups "bacteremia without cardiac involvement (BasAC)," "definite infectious endocarditis (confirmed IE)," or "possible infectious endocarditis" according to the Duke classification modified by the ISCVID in 2023; uncertain cases will be assessed by an adjudication committee. Untergeted metabolomic analysis will be performed on these blood samples in order to find a metabolic signature able to discriminate patients with endocarditis from those without cardiac involvement. The prediction model will be built using a total of 80 patients, comprising 40 "confirmed IE" patients and 40 "IE excluded" (BasAC) patients. The model will then be validated using a randomly selected sample from the "possible IE" group, according to the Duke classification modified by the ISCVID in 2023.