Informations générales (source: ClinicalTrials.gov)
Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score <3: a Non-inferiority Randomized Controlled Trial
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2024
décembre 2028
14 septembre 2025
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.
Etablissements
Critères
Tous
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"
- 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"