Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score <3: a Non-inferiority Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
France
Bichat Claude Bernard Hospital
RECRUITING
Paris
Contact Information
Primary
Xavier Duval
xavier.duval@aphp.fr
01 40 25 71 35
Backup
Sarah Tubiana
sarah.tubiana@aphp.fr
01 40 25 60 51
Time Frame
Start Date: 2025-05-14
Estimated Completion Date: 2028-12
Participants
Target number of participants: 700
Treatments
Active_comparator: systematic 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.
Experimental: no 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.~
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov