RecruitingNot ApplicableNCT06457386

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

700 participants

Start Date

May 14, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is asking whether patients hospitalized with Staphylococcus aureus (Staph) bacteria in their blood — but who are at low risk for heart complications — actually need an echocardiogram (heart ultrasound) as part of their workup. It's trying to determine if this test can be safely skipped in lower-risk patients. **You may be eligible if...** - You are 18 or older - You are hospitalized and have at least one blood culture positive for Staphylococcus aureus - A follow-up blood culture taken 48 hours later came back negative - Your VIRSTA score (a tool to predict heart infection risk) is less than 3 (low risk) **You may NOT be eligible if...** - Your positive culture came only through an intravenous catheter (not a true blood infection) - You were transferred to the hospital specifically for Staph bacteremia management from another facility Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREsystematic echocardiography

"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. "

PROCEDUREno echocardiography 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)

Bichat Claude Bernard Hospital

Paris, France

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NCT06457386


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