Clinical trial NCT06457386: Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3
Official title: Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score <3: a Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Staphylococcus Aureus
Bacteremia
Infective Endocarditis
Keywords: VIRSTA score < 3
Staphylococcus aureus bacteraemia
Echocardiography
Infective endocarditis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion criteria

* 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; Exclusion criteria
* 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;
* 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"

Primary outcomes:
measure: All causes mortality
timeFrame: 90 Days
measure: SAB relapse microbiologically confirmed
timeFrame: 90 Days
Secondary outcomes:
measure: Number of definite IE according to ESC 2023 criteria
timeFrame: the end of hospital stay, up to 90 days
measure: Number of definite IE according to ESC 2023 criteria
timeFrame: 90 Days
measure: Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism)
timeFrame: the end of hospital stay, up to 90 days
measure: Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism)
timeFrame: 90 Days
measure: Length of hospitalization (days)
timeFrame: 180 Days
measure: All-causes mortality
timeFrame: 180 Days
measure: Number of SAB relapse
timeFrame: 90 Days
measure: Cost difference between the two strategies
timeFrame: 90 Days
measure: quality of life measured by EQ5D5L
timeFrame: 180 Days
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Claude Bernard Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Xavier Duval
role: PRINCIPAL_INVESTIGATOR
References: