Staphylococcus Aureus BacteremiaFEN-AUREUSNCT06574399
Identification and Validation of Clinical Phenotypes in Staphylococcus Aureus Bacteremia and Their Association With Mortality and Development of Complicated Bacteremia
An observational study of Staphylococcus Aureus Bacteremia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus Bacteremia
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with clinically significant Staphylococcus aureus bacteremia
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
Belén Gutiérrez Gutiérrez, 618442702, belengutiguti@hotmail.com
Elisa Moreno Mellado, 617245402, elisamoreno500@hotmail.com
About this study
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:
- Evaluate its reproducibility and correlation with mortality
- Derive and validate a simplified probabilistic model for phenotype assignment
- External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort
- Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes.
- Conditions
- Staphylococcus Aureus Bacteremia
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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.
Measured: 34 months
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)
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 May 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574399
- Sponsor's protocol ID
- FIS-FENAUREUS-2022-01
- Acronym
- FEN-AUREUS
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Validation of Clinical Phenotypes in Staphylococcus Aureus Bacteremia and Their Association With Mortality and Development of Complicated Bacteremia
- ClinicalTrials.gov ID
- NCT06574399
- Acronym / sponsor ID
- FEN-AUREUS / FIS-FENAUREUS-2022-01
- Conditions
- Staphylococcus Aureus Bacteremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate its reproducibility and correlation with mortality
- Derive and validate a simplified probabilistic model for phenotype assignment
- External validation of the simplified probabilistic phenotype assignment model found and its association with mortality and development of complicated bacteremia in a prospective cohort
- Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with clinically significant Staphylococcus aureus bacteremia
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
- Patients with non-clinically significant bacteremia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
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
Apply microbiological, biochemical and immunological techniques to explain the physiopathological and genetic mechanisms underlying the phenotypes
Time frame: 34 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus Bacteremia, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Moreno, Pharmacist (+34626909638, elisamoreno50@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.