An interventional study of Echocardiography evaluation in Staphylococcus Aureus Bacteremia and Infective Endocarditis, sponsored by Puerta de Hierro University Hospital. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Puerta de Hierro University Hospital · Not applicable, Interventional, and Diagnostic
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:
Participants will undergo mandatory transthoracic and transesophageal echocardiography during the first 2 weeks from Staphylococcus aureus bacteremia onset.
2- Hypothesis: Prospective evaluation of a cohort of patients with OAB, who undergo TEE, TTE, will provide insight into the actual risk of IE in those patients at low risk.
3- Objectives:
Estimate the cost-benefit of omitting echocardiographic testing in patients identified as low risk by the above methods.
3- Material and methods:
*Design: Multicenter prospective cohort study.
*Project execution sites: Hospitals with the capacity to detect AFB, contact the patient within 72-96h and the possibility of performing transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) in the center itself. Currently 13 collaborating centers plus the sponsoring center (Hospital Puerta de Hierro).
* Sample size calculation: Sample size calculation was performed in order to estimate the prevalence of IE in patients with OAB identified as low risk using the VIRSTA scale. For a confidence level of 95%, with a loss rate of 10%, precision of 2% and an expected proportion of 2% of IE in low-risk patients, a sample size of 210 VIRSTA-negative patients was calculated. Given that at inclusion it will be unknown whether the patient is VIRSTA negative and that, among the objectives of the study is the identification of other subgroups of low-risk patients, taking into account that approximately 45% of patients with AFB are VIRSTA negative, a total sample size of 470 patients with AFB is estimated.
Systematic performance of TTE and TEE in all included patients. TTE will be performed and reported first, followed by TEE (same or different days). Both tests should be performed within 10 days of the patient's inclusion in the study.
The studies will be performed in each of the centers participating in the project with the latest generation echocardiographic equipment commonly used in each center. All echocardiograms will be anonymized and assigned a correlative patient number.
The acquisition of the images of the vegetation or infectious complication will be zoomed and 3 consecutive cardiac cycles will be recorded and sent in DICOM format (both cine and image) to the centralized imaging laboratory, where interpretation will be performed by at least two cardiologists with expertise in echocardiography.
The cardiologists interpreting the echocardiograms centrally will be blinded to any clinical, microbiological and other complementary test data of the patient, as well as to the local interpretation of the images. The cardiologist interpreting the TTE will be blind to the TEE and vice versa.
Echocardiograms with at least one of the following findings will be considered positive or suggestive of IE:
Endocarditis on prosthetic valve: in addition to all of the above, images compatible with paravalvular leak of new appearance, detected with color Doppler, or valve dehiscence will be considered.
IE will be considered reasonably ruled out when the estimated risk of IE is low enough that the costs and risks of the tests needed for diagnosis (TTE or TEE) outweigh the benefits.
In defining cutoff points for this low risk of IE, we consider several recent publications that estimate the risk of IE above which a patient benefits from such evaluations (8,24), as well as the usefulness of the negative likelihood ratio (LR(-) or likelihood ratio (-)) in predicting this risk, as has been reported by other authors (25). In line with these studies, the following cut-off points are predefined:
If the risk of IE was greater than 5% or the CP(-) of the scale was greater than 0.20, TEE would be considered necessary to safely rule out IE.
Demographic data, comorbidities, mode of acquisition and primary focus of bacteremia, clinical, microbiological, echocardiographic and evolution data from patients' medical records, as well as echocardiographic findings will be collected. Data will be collected from the electronic history of each center and included in an anonymized form in an online medical database platform (eCDR).
*Statistical analysis: Quantitative variables will be presented as median and 25th and 75th percentiles; and qualitative variables by absolute and relative frequencies.
An interval estimation (95%) of the prevalence of IE in patients identified as low risk will be performed using the VIRSTA, PREDICT and POSITIVE scales. The prevalence of IE in patients without any of the identified factors will also be estimated using secondary analyses (see below). The diagnostic validity indices sensitivity, specificity, negative (PC-) and positive (PC+) likelihood ratios, and negative (NPV) and positive predictive values (PPV) vs. the gold standard (modified Duke criteria) will be estimated. With these data, we will estimate the risk of IE in an identified low-risk patient from a population with a prevalence similar to ours. Echocardiography (TTE and/or TEE) will be considered dispensable in patients with SAAB when the estimated risk of IE in patients identified as low risk and the CP(-) of the scale is below the aforementioned predefined cut-off points.
For the study of IE risk factors, univariate inferential analysis will be performed using the Mann-Whitney U test for quantitative variables and with the χ2 test or Fisher's exact test when necessary for qualitative variables. Those variables that are clinically and statistically significant will be included in a multivariate logistic regression model.
Finally, the number of echocardiographic tests, both TTE and TEE that could have been safely omitted using the different approaches will be estimated. For the cost-benefit study, the following risks will be taken into account: increased mortality due to nondiagnosis of IE: 15% (2), increased mortality due to TEE: 0.1% (3), increased mortality due to TTE: 0%. The costs of performing tests are estimated following the catalog of public prices of the Community of Madrid (Order 727/2017): cost TEE: €80.
Bilateral p-values of less than 0.05 will be considered statistically significant. All statistical analyses will be performed using the SPSS version 25 software package.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 470 is above the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Puerta de Hierro University Hospital is the lead sponsor of 48 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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%.
Time frame: 3 years
Prevalence of infective endocarditis in low-risk patients according to PREDICT 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%.
Time frame: 3 years
Prevalence of infective endocarditis in low-risk patients according to POSITIVE 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%.
Time frame: 3 years
Prevalence of infective endocarditis in patients with no identifiable risk factor
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%.
Time frame: 3 years
Plan to share: Yes — IPD will be shared upon reasonable request for other researchers after completion of the study and publication of results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Sep 2025, 23 months after the start.
Of 34 interventional studies with no phase under Endocarditis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 59. This study's planned 23 months is below that.
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Puerta de Hierro University Hospital