Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06574399

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Staphylococcus Aureus Bacteremia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

    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.

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

    Time frame: 34 months

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Elisa Moreno, Pharmacist

CONTACT

[email protected]

+34626909638

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Acronym: FEN-AUREUS

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 27, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.