Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3
Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score <3: a Non-inferiority Randomized Controlled Trial
Assistance Publique - Hôpitaux de Paris
700 participants
May 14, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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;
Exclusion Criteria9
- 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"
Interventions
"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 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. "
Locations(1)
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NCT06457386