Identification and Validation of Clinical Phenotypes in Staphylococcus Aureus Bacteremia and Their Association With Mortality and Development of Complicated Bacteremia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Staphylococcus Aureus Bacteremia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Primary outcome measures
- 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]
Secondary outcome measures (2)
- External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort [Time frame: 34 months]
- Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes [Time frame: 34 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Universitario Virgen Macarena — Seville
Identifiers
NCT: NCT06574399 · FIS-FENAUREUS-2022-01