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

NCT ID: NCT06574399

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Staphylococcus Aureus Bacteremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)


* 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.

FOR EXTENDED STUDY:


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Elisa Moreno, Pharmacist

Role: CONTACT

+34626909638

Facility Contacts

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Belén Gutiérrez Gutiérrez

Role: primary

618442702

Elisa Moreno Mellado

Role: backup

617245402

Other Identifiers

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FIS-FENAUREUS-2022-01

Identifier Type: -

Identifier Source: org_study_id

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