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Recruiting Not applicable

Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3

NCT06457386 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-05-14
Last updated
2025-11-24

Condition(s) studied

Staphylococcus AureusBacteremiaInfective Endocarditis

Investigational drug(s) / intervention(s)

systematic echocardiographyno echocardiography arm

systematic echocardiography: "transthoracic echocardiography (TTE) will be performed as soon as possible within 14 days following the first blood sample collection for SAB diagnosis, completed, if required, by a transoesophageal (TEE) echocardiography based on the judgment of the echocardiographist. SAB in patients of both arms will be treated according to current recommendations, taking into account the result of the echocardiography in the control arm. "

no echocardiography arm: "no echocardiography will be performed unless occurrence of new events evocating IE (extra-cardiac events or positive Staphylococcus aureus blood culture), based on the clinical judgment of the investigator. SAB in patients of both arms will be treated according to current recommendations, taking into account the result of the echocardiography in the control arm. "

Study summary

Staphylococcus aureus is the most frequent cause of both healthcare-associated and community-acquired bloodstream infections worldwide. Infective endocarditis (IE) has been detected in 5-17% of cases and is a determinant of poor prognosis. The investigators developed a score (the VIRSTA score) based on patients' characteristics to rule out IE with high confidence (negative predictive value (NPV) above 99%) in patients with SAB. This score, with a cut-off of 3 has been externally validated by two international studies which have also established its high NPV. The 2023 European society of cardiology (ESC) guidelines state that echocardiography should be considered in all patients with Staphylococcus aureus bacteremia (SAB) using risk scores (including VIRSTA score) to guide the use or not of echocardiography. While recommended, the investigators think that VIRSTA score must be evaluated in terms of patients' outcome.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria * Volunteers over 18 years of age; * Hospitalized with at least one blood culture positive for Staphylococcus aureus; * At the time of inclusion, negative control blood culture performed 48 hours after the first Staphylococcus aureus blood culture collection; * VIRSTA score \< 3; Exclusion criteria * Patient with catheter colonization without SAB, defined as positive blood cultures only through vascular access device specimen; * Patient referred to the hospital for the management of IE; * Contra indication to transthoracic echocardiography (TTE); * Echocardiography already performed before inclusion (TTE or TEE) for the current SAB; * Pregnancy; * Patient under guardianship or trusteeship. * Absence of written informed consent from the patient * No affiliation to social security (beneficiary or assignee) * Subject already involved in another interventional clinical research for which echocardiography must be done"

Primary outcome measure(s)

  • All causes mortality — 90 Days
  • SAB relapse microbiologically confirmed — 90 Days
    Relapse of SAB is defined in patients with bacteriologic success as the isolation of a strain of Staphylococcus aureus with in vitro antibiotic susceptibility pattern similar to that of the Staphylococcus aureus strain isolated at inclusion. Relapse will be confirmed at the end of the study by an independent adjudication committee

Trial sites (1)

FacilityCityRegionStatus
Bichat Claude Bernard Hospital Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06457386 on ClinicalTrials.gov ↗ ← All trials in France