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

NCT06574399 | Recruiting

• 1 other identifier: FIS-FENAUREUS-2022-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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:

1. 1.Evaluate its reproducibility and correlation with mortality
2. 2.Derive and validate a simplified probabilistic model for phenotype assignment
3. 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. 4.Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes.

Conditions

Staphylococcus Aureus Bacteremia

Outcome Measures

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

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

  1 month

Secondary Outcomes (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

  34 months

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

  34 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with clinically significant Staphylococcus aureus bacteremia

You may qualify if:

• 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)

You may not qualify if:

• Patients with non-clinically significant bacteremia.
• Patients under palliative sedation at the time of bacteremia report.
• Polymicrobial bacteremia.
• FOR EXTENDED STUDY:
• 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)
• Patients with non-clinically significant bacteremia.
• Patients under palliative sedation at the time of bacteremia report.
• Polymicrobial bacteremia.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Central Study Contacts

Elisa Moreno, Pharmacist

CONTACT

+34626909638; elisamoreno50@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 27, 2024
• Study Start: May 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: March 31, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)