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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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. "
• Процедура 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. "

Первичные конечные точки

• All causes mortality [Срок оценки: 90 Days]
• SAB relapse microbiologically confirmed [Срок оценки: 90 Days]

Вторичные конечные точки (9)

• Number of definite IE according to ESC 2023 criteria [Срок оценки: the end of hospital stay, up to 90 days]
• Number of definite IE according to ESC 2023 criteria [Срок оценки: 90 Days]
• Number of IE valvular cardiac surgery and indications (heart failure, uncontrolled infection or prevention of embolism) [Срок оценки: 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) [Срок оценки: 90 Days]
• Length of hospitalization (days) [Срок оценки: 180 Days]
• All-causes mortality [Срок оценки: 180 Days]
• Number of SAB relapse [Срок оценки: 90 Days]
• Cost difference between the two strategies [Срок оценки: 90 Days]
• quality of life measured by EQ5D5L [Срок оценки: 180 Days]

Критерии участия

Критерии включения

• 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"

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Bichat Claude Bernard Hospital — Paris

Идентификаторы

NCT: NCT06457386 · APHP220807 · 2023-A01572-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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