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

NCT06457386 | Recruiting

• 2 other identifiers: APHP2208072023-A01572-43
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Aureus; Bacteremia; Infective Endocarditis

Keywords

VIRSTA score < 3; Staphylococcus aureus bacteraemia; Echocardiography; Infective endocarditis

Outcome Measures

Primary Outcomes (2)

• All causes mortality

  90 Days

• SAB relapse microbiologically confirmed

  Relapse of SAB is defined in patients with bacteriologic success as the isolation of a strain of Staphylococcus aureus with in vitro antibiotic susceptibility pattern similar to that of the Staphylococcus aureus strain isolated at inclusion. Relapse will be confirmed at the end of the study by an independent adjudication committee

  90 Days

Secondary Outcomes (9)

• Number of definite IE according to ESC 2023 criteria

  the end of hospital stay, up to 90 days

• Number of definite IE according to ESC 2023 criteria

  90 Days

• Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism)

  the end of hospital stay, up to 90 days

• Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism)

  90 Days

• Length of hospitalization (days)

  180 Days

Study Arms (2)

systematic echocardiography arm

ACTIVE COMPARATOR

"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: systematic echocardiography

no echocardiography arm

EXPERIMENTAL

"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. "

Procedure: no echocardiography arm

Interventions

systematic echocardiography PROCEDURE

"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. "

systematic echocardiography arm

no echocardiography arm PROCEDURE

"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. "

no echocardiography arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers over 18 years of age;
• Hospitalized with at least one blood culture positive for Staphylococcus aureus;

You may not qualify if:

• 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);
• 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"

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat Claude Bernard Hospital

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections; Bacteremia; Endocarditis

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Xavier Duval

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Duval

CONTACT

01 40 25 71 35; xavier.duval@aphp.fr

Sarah Tubiana

CONTACT

01 40 25 60 51; sarah.tubiana@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 13, 2024
• Study Start: May 14, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-10

Locations

FR (1)