NCT06457386 Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3
| NCT ID | NCT06457386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Staphylococcus Aureus |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2025-05-14 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 700 participants in total. It began in 2025-05-14 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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"
Contact & Investigator
Xavier Duval
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT06457386 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Staphylococcus Aureus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06457386 currently recruiting?
Yes, NCT06457386 is actively recruiting participants. Contact the research team at xavier.duval@aphp.fr for enrollment information.
Where is the NCT06457386 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06457386 clinical trial?
NCT06457386 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Xavier Duval at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 700 participants.