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Could many staph patients skip heart scans? major trial aims to find out

NCT ID NCT06457386

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether people with a staph bloodstream infection and a low risk score (VIRSTA score less than 3) can safely avoid a routine heart ultrasound. About 700 participants will be randomly assigned to either get the ultrasound or not. The goal is to see if skipping it leads to similar rates of death or infection relapse, potentially simplifying care for many patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that many patients with staph bloodstream infections can safely avoid routine heart ultrasound, simplifying care and reducing costs.
What could go wrong
This is a non-inferiority trial, so it may not prove that skipping echocardiography is better—only that it is not worse. The results may not apply to patients with higher risk scores.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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"

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis endocarditis infective endocarditis staphylococcal infection staphylococcus aureus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacteremia Infective endocarditis Staphylococcus aureus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bichat Claude Bernard Hospital

    RECRUITING

    Paris, 75018, France

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