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

Обзор

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.

Первичные конечные точки

• 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 [Срок оценки: 1 month]

Вторичные конечные точки (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 [Срок оценки: 34 months]
• Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes [Срок оценки: 34 months]

Критерии участия

FOR STANDARD STUDY:

Критерии включения

• 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)

Критерии исключения

• 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:

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 1 центр

• Hospital Universitario Virgen Macarena — Seville

Идентификаторы

NCT: NCT06574399 · FIS-FENAUREUS-2022-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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