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

Not Applicable
Not yet recruiting
Conditions
Bacteremia
Staphylococcus Aureus
Infective Endocarditis
Interventions
Procedure: systematic echocardiography
Procedure: no echocardiography arm
Registration Number
NCT06457386
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
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.

Detailed Description

In the interventional arm (no-echocardiography strategy) without echocardiography, at the individual level, not performing an echocardiography will avoid a useless examination, the mobilization of the patient and the discomfort related to its performance.

In this arm, the theoretical risk is to diagnose Infective endocarditis (IE ) only at a later phase stage, i.e., at a phase of symptomatic manifestation of valve regurgitation or at the occurrence of relapse of bacteremia due to insufficient duration of antibiotic treatment. It should be noted that patients with prosthetic valve, who have "de facto" a VIRSTA score \> 3, will therefore not be included in the protocol. Given the expected rarity of IE in patients with a VIRSTA score \<3 and the theoretical consequences of not performing echocardiography, the primary endpoint chosen will be mortality and Staphylococcus aureus bacteraemia (SAB) relapse. The endpoint will be assessed at 90 days and not at discharge to capture relapses of inadequately treated bacteremia and the mid-term consequences of a possible delay in IE diagnosis.

On a collective scale, not performing echocardiography in many patients in whom it is not useful will allow resources to be allocated to the individuals who need it most.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
700
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
systematic echocardiography armsystematic 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. "
no echocardiography armno 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. "
Primary Outcome Measures
NameTimeMethod
SAB relapse microbiologically confirmed90 Days

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

All causes mortality90 Days
Secondary Outcome Measures
NameTimeMethod
All-causes mortality180 Days
Number of definite IE according to ESC 2023 criteria90 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
quality of life measured by EQ5D5L180 Days
Number of SAB relapse90 Days
Cost difference between the two strategies90 Days

Cost-effectiveness analysis if there is a difference in the number of events in each arm

Trial Locations

Locations (1)

Bichat Claude Bernard Hospital

🇫🇷

Paris, France

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