Actively Recruiting
Echocardiography Versus No Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score Below 3: a Randomized Controlled Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-24
700
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Staphylococcus aureus bloodstream infections are a common and serious health concern worldwide, with infective endocarditis (IE) complicating 5-17% of these cases and leading to worse outcomes. Researchers have developed the VIRSTA score to identify patients with low risk of IE, aiming to reduce unnecessary echocardiography. This trial evaluates whether skipping echocardiography in patients with a VIRSTA score under 3 affects mortality and relapse of infection. Participants are randomly assigned to one of two groups: one group will receive systematic echocardiography, including transthoracic and possibly transoesophageal echocardiography within 14 days of diagnosis, while the other group will not have echocardiography unless new signs suggestive of IE appear. Both groups will receive standard antibiotic treatment adjusted based on echocardiography results in the control group. The study focuses on outcomes measured at 90 days after diagnosis. During the study, participants will be monitored for death and relapse of Staphylococcus aureus bacteremia. Additional assessments include detection of definite IE, need for heart valve surgery, hospital stay length, quality of life, and healthcare costs up to 180 days. The study includes careful follow-up to capture any delayed diagnosis or complications related to IE, ensuring comprehensive evaluation of patient outcomes.
CONDITIONS
Brief Title
Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Hospitalized with at least one positive blood culture for Staphylococcus aureus
- Negative control blood culture performed 48 hours after the first positive culture
- VIRSTA score less than 3
- Provide written informed consent
- Affiliated with social security (beneficiary or assignee)
You will not qualify if you...
- Catheter colonization without bloodstream infection
- Referred for management of infective endocarditis
- Contraindication to transthoracic echocardiography
- Echocardiography already performed for current infection
- Pregnancy
- Under guardianship or trusteeship
- No written informed consent
- Not affiliated with social security
- Participation in another interventional clinical research requiring echocardiography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days following diagnosis
Participants in the systematic echocardiography arm will have transthoracic echocardiography performed within 14 days after diagnosis, possibly completed by transoesophageal echocardiography based on clinical judgment. Participants in the no echocardiography arm will not have echocardiography unless new events suggestive of infective endocarditis occur.
1 to 2 visits depending on clinical events
Duration - 90 days
Participants are monitored for mortality and relapse of Staphylococcus aureus bacteraemia for up to 90 days following diagnosis to capture relapses and mid-term consequences of delayed diagnosis.
Follow-up visits as per clinical care up to 90 days
Trial Site Locations
Total: 1 location
1
Bichat Claude Bernard Hospital
Paris, France, 75018
Actively Recruiting
Research Team
X
Xavier Duval
S
Sarah Tubiana
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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