An interventional study of systematic echocardiography and no echocardiography arm in Staphylococcus Aureus, Bacteremia and Infective Endocarditis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
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.
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.
303 studies on the registry are indexed under Staphylococcal Infections; 34 are open to participants now.
This study's planned enrollment of 700 is above the median of 124 across 198 interventional studies indexed under Staphylococcal Infections.
Browse Staphylococcal Infections studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Inclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
"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 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
"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 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. "
All causes mortality
Time frame: 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
Time frame: 90 Days
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
Number of definite IE according to ESC 2023 criteria
Time frame: 90 Days
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
Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism)
Time frame: 90 Days
Length of hospitalization (days)
Time frame: 180 Days
All-causes mortality
Time frame: 180 Days
Number of SAB relapse
Time frame: 90 Days
Cost difference between the two strategies
Cost-effectiveness analysis if there is a difference in the number of events in each arm
Time frame: 90 Days
quality of life measured by EQ5D5L
Time frame: 180 Days
Plan to share: Undecided
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