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RecruitingNCT06574399FEN-AUREUSUpdated Aug 27, 2024

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

An observational study in Staphylococcus Aureus Bacteremia, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Staphylococcus Aureus Bacteremia

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03

In context

Bacteremia

297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 300 across 125 observational studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults with clinically significant Staphylococcus aureus bacteremia

Eligibility criteria

FOR STANDARD STUDY:

Inclusion Criteria:

  • Adults and children with 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, 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

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)

    Time frame: 1 month

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

    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.

    Time frame: 34 months

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

    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)

    Time frame: 34 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06574399
Responsible party
Sponsor
First posted
Aug 27, 2024
Start date
May 1, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Aug 27, 2024

Study contacts

Elisa Moreno, Pharmacist
Contact
elisamoreno50@hotmail.com
+34626909638

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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