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Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3

NCT06457386 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

  • Staphylococcus Aureus
  • Bacteremia
  • Infective Endocarditis

Interventions

PROCEDURE

systematic 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. "

PROCEDURE

no 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. "

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Xavier Duval · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06457386 on ClinicalTrials.gov