Actively Recruiting
Identification and Validation of Clinical Phenotypes in Staphylococcus Aureus Bacteremia and Their Association With Mortality and Development of Complicated Bacteremia
Led by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Updated on 2024-08-27
1000
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to examine whether different clinical types of patients, including adults and children, develop Staphylococcus aureus bacteremia. The study aims to evaluate the reproducibility of these phenotypes and their correlation with mortality. It also seeks to create and validate a simplified probabilistic model for assigning phenotypes and to understand the biological and genetic mechanisms behind these clinical types using microbiological, biochemical, and immunological methods. The study involves analyzing retrospective patient data and prospectively validating the simplified phenotype assignment model in a new patient group over a period of up to 34 months. Researchers will apply various laboratory techniques to explore the underlying physiological and genetic causes of the different clinical phenotypes. This includes external validation of the model and studying links between phenotypes, mortality, and the development of complicated bacteremia. Participants will be assessed based on clinical criteria for Staphylococcus aureus bacteremia, including signs like fever, rapid heart rate, or organ failure. Outcomes measured include the accuracy of phenotype classification, its association with mortality, and insights into disease mechanisms. The main outcome is evaluated within one month, while extended follow-up and additional laboratory investigations continue for up to 34 months. This allows researchers to monitor participants' clinical progress and collect detailed biological data over time.
CONDITIONS
Brief Title
Identification and Validation of Clinical Phenotypes in Staphylococcus Aureus Bacteremia and Their Association With Mortality and Development of Complicated Bacteremia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults and children with clinically significant Staphylococcus aureus bacteremia
- Presence of at least two systemic inflammatory response criteria such as fever, rapid heartbeat, rapid breathing, lowered awareness, low blood pressure, abnormal white blood cell count, or organ failure
- Adults with clinically significant Staphylococcus aureus bacteremia included in the Standard Study (for Extended Study)
- Selected at random as one of the model phenotypes until completing recruitment (only at specific centers for Extended Study)
You will not qualify if you...
- Patients with non-clinically significant bacteremia
- Death within 48 hours after bacteremia detection or life expectancy less than 48 hours for retrospective cases
- Patients under palliative sedation at the time of bacteremia report
- Polymicrobial bacteremia (infection with multiple bacterial types)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 34 months
Participants with Staphylococcus aureus bacteremia are observed to identify clinical phenotypes and assess their association with mortality and complicated bacteremia.
Visits scheduled according to clinical assessments over the study period
Trial Site Locations
Total: 1 location
1
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
Research Team
E
Elisa Moreno, Pharmacist
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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