Evaluation of the Usefulness of Echocardiography in Patients With Staphylococcus Aureus Bacteremia (ET-AUREUS Study).

NCT05862025 | Unknown

• 1 other identifier: PI22/00275
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective interventionist cohort study is to assess the prevalence of infective endocarditis in patients with Staphylococcus aureus bacteremia at low risk of this complication. The main questions it aims to answer are:

• Determine whether the risk of infective endocarditis in patients with Staphylococcus aureus bacteriemia identified as low-risk, using the VIRSTA score, is low enough to safely omit transthoracic or transesophageal echocardiography.
• Determine whether the risk of infective endocarditis in patients with Staphylococcus aureus bacteriemia in patients with no identifiable risk factor is low enough to safely omit transthoracic or transesophageal echocardiography.
• Calculate a cost-benefit estimate of omitting echocardiographic testing in patients identified as low-risk by means of the above methods. Participants will undergo mandatory transthoracic and transesophageal echocardiography during the first 2 weeks from Staphylococcus aureus bacteremia onset.

Conditions

Staphylococcus Aureus Bacteremia; Infective Endocarditis

Keywords

Staphylococcus aureus; bacteremia; infective endocarditis; risk factors; echocardiography

Outcome Measures

Primary Outcomes (1)

• Prevalence of infective endocarditis in low-risk patients according to VIRSTA score

  If the prevalence of infective endocarditis is lower than 0.5% it would be considered that no echocardiography is needed to exclude infective endocarditis. If the prevalence is greater than 5%, a transesophageal echocardiography will be considered needed. If the prevalence is between 0.5-5%, transesophageal echocardiography will be consireded needed unless the prevalence of those patients with negative transthoracic echocardiography is below 1%.

  3 years

Secondary Outcomes (3)

• Prevalence of infective endocarditis in low-risk patients according to PREDICT score

  3 years

• Prevalence of infective endocarditis in low-risk patients according to POSITIVE score

  3 years

• Prevalence of infective endocarditis in patients with no identifiable risk factor

  3 years

Study Arms (1)

Echocardiography intervention

OTHER

Patients will undergo mandatory transthoracic echocardiography during assessment of Staphylococcus aureus bacteremia. Later, they will also undergo mandatory transesophageal echocardiography. Both test will be performed during the first 14 days from bacteremia onset.

Diagnostic Test: Echocardiography evaluation

Interventions

Echocardiography evaluation DIAGNOSTIC_TEST

Patients will undergo mandatory transthoracic echocardiography during assessment of Staphylococcus aureus bacteremia. Later, they will also undergo mandatory transesophageal echocardiography. Both test will be performed during the first 14 days from bacteremia onset.

Echocardiography intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Staphylococcus aureus bacteremia

You may not qualify if:

• Previous episode of Staphylococcus aureus bacteremia.
• Pregnant women
• Patients younger than 18 years old.
• Patients with contraindication of transesophageal echocardiography, including: esophageal varices, other serious esophageal diseases (including tumors, perforation, diverticulum and previous esophageal surgery), severe coagulopathy (platelets count lower than 50.000 cel/mL or I.N.R above 4), low consciousness, recent upper gastroesophageal bleeding, serious espinal vertebrae pathology (previous radiotherapy, active spondylodiscitis, severe spondylarthrosis)
• Abscense of written informed consent or patient's negative to undergo echocardiography evaluation.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead
• Hospital Rafael Mendez: collaborator
• Gregorio Marañón Hospital: collaborator
• University Hospital Virgen de las Nieves: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Mutua de Terrassa: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator
• Hospital Infanta Sofia: collaborator
• Hospitales Universitarios Virgen del Rocío: collaborator
• Hospital de Alava: collaborator
• Hospital de Donosti: collaborator
• Hospital de Basurto: collaborator
• Hospital Universitario Virgen Macarena: collaborator
• Hospital Santa Cruz de Tenerife: collaborator

Study Sites (1)

University Hospital Puerta de Hierro

Majadahonda, Madrid, 28320, Spain

RECRUITING

MeSH Terms

Conditions

Endocarditis; Staphylococcal Infections; Bacteremia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Single arm study, no masking needed
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: A\>ll patients will undergo mandatory transesophageal and transthoracic echocardiography during the first 2 weeks after Staphylococcus aureus bacteremia onset

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 17, 2023
• Study Start: September 4, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be shared upon reasonable request for other researchers after completion of the study and publication of results.
• Access Criteria: IPD will be shared upon reasonable request for other researchers after completion of the study and publication of results.

Locations

ES (1)