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NCT Number: NCT06457386

Echocardiography Versus no Echocardiography in S. Aureus Bacteraemia and VIRSTA Score < 3

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bichat Claude Bernard Hospital

Paris, 75018, France

Location status: Recruiting

Location contact

Xavier Duval, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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"

Treatment and study plan

systematic echocardiography

Procedure

"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

Procedure

"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. "

Primary outcomes

  1. All causes mortality

    Time frame: 90 Days

  2. 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

Secondary outcomes

  1. Number of definite IE according to ESC 2023 criteria

    Time frame: the end of hospital stay, up to 90 days

    An independent adjudication committee will classify definite, possible or excluded IE according to the 2023 ESC criteria

  2. Number of definite IE according to ESC 2023 criteria

    Time frame: 90 Days

  3. 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

  4. Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism)

    Time frame: 90 Days

  5. Length of hospitalization (days)

    Time frame: 180 Days

  6. All-causes mortality

    Time frame: 180 Days

  7. Number of SAB relapse

    Time frame: 90 Days

  8. Cost difference between the two strategies

    Time frame: 90 Days

    Cost-effectiveness analysis if there is a difference in the number of events in each arm

  9. quality of life measured by EQ5D5L

    Time frame: 180 Days

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Tubiana

CONTACT

[email protected]

01 40 25 60 51 ext. 33

Xavier Duval

CONTACT

[email protected]

01 40 25 71 35 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: VIRSTA-VAL

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 13, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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