Identifying clinical phenotypes in Staphylococcus aureus bacteremia and their impact on mortality

Identification and Validation of Clinical Phenotypes in Staphylococcus Aureus Bacteremia and Their Association With Mortality and Development of Complicated Bacteremia

This study is trying to find different types of Staphylococcus aureus infections in patients to see how they affect survival rates and to create a simpler way to identify these types.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Academic / other)
• Locations: 1 site (Seville)
• Trial ID: NCT06574399 on ClinicalTrials.gov

What this trial studies

This observational study aims to retrospectively identify and validate different clinical phenotypes in patients with Staphylococcus aureus bacteremia. It will evaluate the reproducibility of these phenotypes and their correlation with mortality rates. Additionally, the study seeks to derive and validate a simplified probabilistic model for phenotype assignment and to explore the underlying physiological and genetic mechanisms using microbiological, biochemical, and immunological techniques. A prospective cohort will also be used for external validation of the model's effectiveness.

Who should consider this trial

Good fit: Ideal candidates include adults and children with clinically significant Staphylococcus aureus bacteremia who meet specific systemic inflammatory response criteria.

Not a fit: Patients with non-clinically significant bacteremia or those expected to live less than 48 hours after detection will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved patient stratification and targeted treatment strategies for those with Staphylococcus aureus bacteremia.

How similar studies have performed: While similar studies have explored clinical phenotypes in bacteremia, this specific approach to phenotype validation and mortality association is relatively novel.

Eligibility criteria

FOR STANDARD STUDY:

Inclusion Criteria:

* Adults and children with clinically significant Staphylococcus aureus bacteremia (at least two classic systemic inflammatory response criteria: fever, tachycardia, tachypnea, lowered awareness, low blood pressure, leucocytosis/leucopenia, organ failure)

Exclusion Criteria:

* Patients with non-clinically significant bacteremia.
* Death within 48 hours after detection of bacteremia for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases.
* Patients under palliative sedation at the time of bacteremia report.
* Polymicrobial bacteremia.

FOR EXTENDED STUDY:

Inclusion Criteria:

* Adults with clinically significant Staphylococcus aureus bacteremia included in the Standard Study
* Selected at random as one of the model phenotypes until completing recruitment (only HUVM and HUVV)

Exclusion Criteria:

* Patients with non-clinically significant bacteremia.
* Death within 48 hours after detection of bacteremia for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases, life expectancy less than 48 hours for the inclusion of retrospective cases.
* Patients under palliative sedation at the time of bacteremia report.
* Polymicrobial bacteremia.

Where this trial is running

Seville

• Hospital Universitario Virgen Macarena — Seville, Spain (Recruiting)

Study contacts

• Study coordinator: Elisa Moreno, Pharmacist

Conditions Staphylococcus Aureus Bacteremia