Staphylococcus AureusVIRSTA-VALNCT06457386
Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3
A study testing systematic echocardiography and no echocardiography arm in people with Staphylococcus Aureus and Bacteremia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus, Bacteremia, Infective Endocarditis
- What is being tested?
- systematic echocardiography and no echocardiography arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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"
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Bichat Claude Bernard Hospital
Paris, 75018
Xavier Duval, MD, PhD, xaviel.duval@aphp.fr
About this study
Official title: Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score <3: a Non-inferiority Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Staphylococcus Aureus, Bacteremia, Infective Endocarditis
- Being tested
- systematic echocardiography, no echocardiography arm
- Keywords
- VIRSTA score < 3, Staphylococcus aureus bacteraemia, Echocardiography, Infective endocarditis
- Medical subject headings
- Staphylococcal Infections, Bacteremia, Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic echocardiographyProcedure or surgery
"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 armProcedure or surgery
"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. "
| Study group | Role | What they receive |
|---|---|---|
| systematic echocardiography arm | 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. " Receives: Procedure: systematic echocardiography |
| no echocardiography arm | 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.
" Receives: Procedure: no echocardiography arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
All causes mortality
Measured: 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
Measured: 90 Days
Secondary outcomes (9)
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
Measured: the end of hospital stay, up to 90 days
Number of definite IE according to ESC 2023 criteria
Measured: 90 Days
Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism)
Measured: 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)
Measured: 90 Days
Length of hospitalization (days)
Measured: 180 Days
All-causes mortality
Measured: 180 Days
Number of SAB relapse
Measured: 90 Days
Cost difference between the two strategies
Cost-effectiveness analysis if there is a difference in the number of events in each arm
Measured: 90 Days
quality of life measured by EQ5D5L
Measured: 180 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start14 May 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Duval, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457386
- Sponsor's protocol ID
- APHP220807
- Other IDs
- 2023-A01572-43
- Acronym
- VIRSTA-VAL
- Status last verified
- Oct 2025
- First submitted
- 3 Jun 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography Versus no Echocardiography in Individuals With Staphylococcus Aureus Bacteremia and a VIRSTA Score <3: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06457386
- Acronym / sponsor ID
- VIRSTA-VAL / APHP220807
- Conditions
- Staphylococcus Aureus, Bacteremia, Infective Endocarditis
- Keywords
- VIRSTA score < 3, Staphylococcus aureus bacteraemia, Echocardiography, Infective endocarditis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| systematic echocardiography arm | Active comparator | Procedure: systematic echocardiography"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 arm | Experimental | Procedure: 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. " |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systematic echocardiography"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 or surgery | systematic echocardiography arm |
| 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. " | Procedure or surgery | no echocardiography arm |
Primary outcome
All causes mortality
Time frame: 90 Days
SAB relapse microbiologically confirmed
Time frame: 90 Days
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
9 secondary outcomes
Number of definite IE according to ESC 2023 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
Time frame: 90 Days
quality of life measured by EQ5D5L
Time frame: 180 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xavier Duval principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systematic echocardiography and no echocardiography arm in people with Staphylococcus Aureus and Bacteremia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier Duval (01 40 25 71 35 ext. 33, xavier.duval@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All causes mortality (time frame: 90 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.