Recruiting

VIRSTA-VALEchocardiography Use in Staphylococcus Aureus Bacteremia with Low VIRSTA Score

Study Aim

This study will evaluate how effective echocardiography is in diagnosing complications and preventing death or relapse in patients with Staphylococcus aureus bacteremia who have a low VIRSTA score.

What is being tested

no echocardiography arm

+ systematic echocardiography

Procedure

Who is being recruted

Bacterial Infections and Mycoses+11

+ Bacterial Infections

+ Cardiovascular Diseases

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Interventional

Study Start: May 2025

See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris

Study ContactXavier DuvalMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 14, 2025

Actual date on which the first participant was enrolled.

This study focuses on individuals with Staphylococcus aureus bacteremia, which is a type of bacterial infection in the blood. Researchers are exploring whether it's necessary to perform echocardiography, a heart imaging test, on patients who have a low VIRSTA score of less than 3. A VIRSTA score helps predict the risk of developing a heart infection called infective endocarditis (IE). The study aims to see if skipping this test can be just as effective as performing it in low-risk patients, potentially saving resources and sparing patients from unnecessary procedures. This research is important as it could lead to better resource allocation in healthcare and reduce patient discomfort without increasing risks. Participants in this study are divided into two groups. One group will not have an echocardiography test, while the other group might. The study measures outcomes based on mortality and the recurrence of Staphylococcus aureus bacteremia over a 90-day period. The goal is to determine if not performing the echocardiography poses any increased risk of delayed diagnosis of heart infections. Avoiding unnecessary echocardiography can free up medical resources for patients who truly need them, while also minimizing unnecessary discomfort for patients. However, there is a theoretical risk that heart infections may be diagnosed later if symptoms are not apparent early on.

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

NCT06457386

Principal SponsorAssistance Publique - Hôpitaux de Paris

Study ContactXavier DuvalMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

700 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsCardiovascular DiseasesEndocarditisHeart DiseasesInfectionsInflammationPathologic ProcessesStaphylococcal InfectionsPathological Conditions, Signs and SymptomsBacteremiaGram-Positive Bacterial InfectionsSystemic Inflammatory Response SyndromeSepsis

Criteria

4 inclusion criteria required to participate

Volunteers over 18 years of age;

At the time of inclusion, negative control blood culture performed 48 hours after the first Staphylococcus aureus blood culture collection;

Hospitalized with at least one blood culture positive for Staphylococcus aureus;

VIRSTA score \< 3;

9 exclusion criteria prevent from participating

Contra indication to transthoracic echocardiography (TTE);

Absence of written informed consent from the patient

Patient referred to the hospital for the management of IE;

No affiliation to social security (beneficiary or assignee)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

"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. "

Group II

Active Comparator

"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. "

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Bichat Claude Bernard Hospital

Paris, FranceOpen Bichat Claude Bernard Hospital in Google Maps

Recruiting

One Study Center