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

ConditionsStaphylococcus AureusBacteremiaInfective Endocarditis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • systematic echocardiography

    Procedure/Surgery

    "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. "

  • no echocardiography arm

    Procedure/Surgery

    "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. "

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: systematic echocardiography armActive comparator 1 intervention
Group B: no echocardiography armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

All causes mortality

Time frame
90 Days
2

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

Time frame
90 Days

Secondary outcomes

1

Number of definite IE according to ESC 2023 criteria

An independent adjudication committee will classify definite, possible or excluded IE according to the 2023 ESC criteria

Time frame
the end of hospital stay, up to 90 days
2

Number of definite IE according to ESC 2023 criteria

Time frame
90 Days
3

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

Time frame
the end of hospital stay, up to 90 days
4

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

Time frame
90 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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