Echocardiography versus no echocardiography for Staphylococcus aureus bloodstream infection with VIRSTA score <3

Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score <3: a Non-inferiority Randomized Controlled Trial

This trial tests whether it is safe to skip routine echocardiography in adults hospitalized with Staphylococcus aureus bloodstream infection who have a VIRSTA score under 3.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 700 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Paris)
• Trial ID: NCT06457386 on ClinicalTrials.gov

What this trial studies

Adults hospitalized with at least one positive blood culture for Staphylococcus aureus and a VIRSTA score <3 are assigned to either routine echocardiography or a no-echocardiography strategy. The trial uses negative follow-up blood cultures at 48 hours and excludes patients who already had echocardiography, have prosthetic valves, or other contraindications. The primary endpoints are mortality and relapse of Staphylococcus aureus bacteremia measured at 90 days to capture delayed diagnoses of infective endocarditis or inadequate treatment. The design aims to determine whether withholding echocardiography in low-VIRSTA patients reduces unnecessary testing and conserves resources without harming patients.

Who should consider this trial

Good fit: Adults (≥18) hospitalized with at least one blood culture positive for Staphylococcus aureus, a negative control blood culture at 48 hours, a VIRSTA score <3, able to give informed consent, and without prior echocardiography for the current infection are eligible.

Not a fit: Patients with prosthetic valves or other high-risk features (typically VIRSTA ≥3), those already referred for endocarditis care, or those with contraindications to TTE are unlikely to benefit from this no-echocardiography strategy.

Why it matters

Potential benefit: If successful, this approach could safely reduce unnecessary echocardiograms, patient discomfort, and resource use while focusing imaging on higher-risk patients.

How similar studies have performed: The VIRSTA score itself has been externally validated by international studies showing a negative predictive value above 99%, but withholding echocardiography based on VIRSTA has not been widely tested in interventional trials.

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"

Where this trial is running

Paris

• Bichat Claude Bernard Hospital — Paris, France (Recruiting)

Study contacts

• Principal investigator: Xavier Duval — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Xavier Duval

Conditions Staphylococcus Aureus; Bacteremia; Infective Endocarditis; VIRSTA score < 3; Staphylococcus aureus bacteraemia; Echocardiography; Infective endocarditis