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 Sevilla1,000 enrolled

Overview

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: 1. Evaluate its reproducibility and correlation with mortality 2. Derive and validate a simplified probabilistic model for phenotype assignment 3. External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort 4. Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Staphylococcus Aureus Bacteremia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

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

Time frame: 1 month

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

Perform a multicenter prospective cohort study (Standard study): All patients who develop S. aureus bacteremia will be assigned a phenotype and followed up for six months to evaluate the differences in mortality and development of complicated bacteremia between phenotypes.

Time frame: 34 months

Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes

Study the genetic (microorganism and patient), immunological, biochemical and microbiological variables in patients representative of the phenotypes selected in the prospective cohort in two hospitals (Extended Study)