Echocardiography versus no echocardiography for Staphylococcus aureus bloodstream infection with VIRSTA score <3
Official title: Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score <3: a Non-inferiority Randomized Controlled Trial
Run by Assistance Publique - Hôpitaux de Paris · NCT06457386 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | May 14, 2025 |
| Main results expected | June 2028 |
| Study ends | December 2028 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT06457386 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Bichat Claude Bernard Hospital
Paris, France Recruiting
Study contacts
- Principal investigator: Xavier Duval — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Xavier Duval
- Email: xavier.duval@aphp.fr
- Phone: 01 40 25 71 35
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Improving oral hygiene to reduce risk of infective endocarditis
This study tests if better oral hygiene, through dental cleaning and education, can help reduce bacteria in the blood for people at risk of infective endocarditis.
-
UllCORE BSI Test for Bloodstream Infections
This study tests whether the UllCORE BSI Test can correctly detect bloodstream infection pathogens and resistance markers from whole blood in people with suspected infection or sepsis.
-
Al[18F]F-NOTA-folate PET imaging in suspected cardiac sarcoidosis and infective endocarditis
This diagnostic test uses a folate-based PET tracer to see if it can help identify inflammation or infection in the heart for people with suspected cardiac sarcoidosis or infective endocarditis.
-
Etiologic Diagnosis Algorithm in Infective Endocarditis
Aiming to see if a combined culture and molecular testing approach can help doctors choose the right antibiotics faster for adults with infective endocarditis.
-
Rifampin-free therapy vs rifampin-containing therapy for staphylococcal prosthetic valve endocarditis
This study tests whether a rifampin-free antibiotic regimen can be as effective as a rifampin-containing regimen for adults with staphylococcal prosthetic valve endocarditis.
-
Beta-lactam plus levofloxacin for streptococcal bacteremia
This trial tests whether adding levofloxacin to standard beta-lactam therapy helps adults with streptococcal bacteremia see better outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.