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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 site in 1 country1,000 target enrollmentMay 1, 2023

ConditionsStaphylococcus Aureus Bacteremia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Staphylococcus Aureus Bacteremia
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Enrollment: 1000
Locations: 1
Primary Endpoint: Determine whether different patient clinical phenotypes develop S. aureus bacteremia, evaluate its reproducibility and correlation with mortality and derive and validate a simplified probabilistic model for phenotype assignment
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this observational study is to determine retrospectively whether different patient clinical phenotypes (adults and children) develop Staphylococcus aureus bacteremia.The main questions it aims to answer qre:

Evaluate its reproducibility and correlation with mortality
Derive and validate a simplified probabilistic model for phenotype assignment
External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort
Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes.

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

March 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Determine whether different patient clinical phenotypes develop S. aureus bacteremia, evaluate its reproducibility and correlation with mortality and derive and validate a simplified probabilistic model for phenotype assignment

Time Frame: 1 month

Analyze the ISAC (International Staphylococcus aureus collaboration) cohort from an international study (11 hospitals in five countries) on Staphylococcus aureus bacteremia (2590 cases)

Secondary Outcomes

External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort(34 months)
Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes(34 months)