Bacterial InfectionsNCT06211829
An Evaluation of a Antimicrobial Stewardship Recommendation Bundle for Staphylococcus Aureus Bloodstream Infections
An observational study of Bacterial Infections, run by Methodist Health System at 1 site in United States.
Trial summary
In July 2020, a bundle (Appendix C) was implemented at Methodist Dallas Medical Center where all patients with SAB were reviewed by the antimicrobial stewardship pharmacist (Monday - Friday from 0700 to 1500), a note outlining optimal interventions was written in the electronic medical record (EMR), and the… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bacterial Infections
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 14 Jul 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 to 85 years
- All sexes
- Adult, Older adult
Study population: 18 years of age SAB during hospital admission a history of a prior SAB during the study period (only first occurrence
Who may be able to join
- 18 years of age SAB during hospital admission
Who cannot join
- Patients with a history of a prior SAB during the study period (only first occurrence included)
- Blood culture collected within 48hours of patient expiring or transitioning to hospice
- Patients discharged or left before culture results were available
- Patients transferred from an outside hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
In July 2020, a bundle (Appendix C) was implemented at Methodist Dallas Medical Center where all patients with SAB were reviewed by the antimicrobial stewardship pharmacist (Monday - Friday from 0700 to 1500), a note outlining optimal interventions was written in the electronic medical record (EMR), and the recommendations were communicated to the primary team via secure messaging or telephone
Read the detailed description
Evaluation of the Staphylococcus aureus bloodstream infection(SAB)bundle recommendations will allow for determination of whether this intervention is impactful and warrants the resources currently devoted to it.
- Conditions
- Bacterial Infections
- Medical subject headings
- Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Staphylococcus Aureus blood stream infections (SAB)
Number of SAB occurring
Measured: 12 weeks
Secondary outcomes (5)
Number of In-hospital mortality
Number of In-hospital mortality
Measured: 12 weeks
number of times of bacteremia
time of bacteremia
Measured: 12 weeks
number of days of stay
duration of hospital stay
Measured: 12 weeks
number of times of readmission
Number time of readmission
Measured: 12 weeks
number of infection
Number of times the infection is occurring
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start18 May 2022
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies 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
- Retrospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211829
- Sponsor's protocol ID
- 016.PHA.2022.D
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Holland TL, Raad I, Boucher HW, Anderson DJ, Cosgrove SE, Aycock PS, Baddley JW, Chaftari AM, Chow SC, Chu VH, Carugati M, Cook P, Corey GR, Crowley AL, Daly J, Gu J, Hachem R, Horton J, Jenkins TC, Levine D, Miro JM, Pericas JM, Riska P, Rubin Z, Rupp ME, Schrank J Jr, Sims M, Wray D, Zervos M, Fowler VG Jr; Staphylococcal Bacteremia Investigators. Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious Adverse Events in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial. JAMA. 2018 Sep 25;320(12):1249-1258. doi: 10.1001/jama.2018.13155.
PubMed 30264119Perez-Rodriguez MT, Sousa A, Lopez-Cortes LE, Martinez-Lamas L, Val N, Baroja A, Nodar A, Vasallo F, Alvarez-Fernandez M, Crespo M, Rodriguez-Bano J. Moving beyond unsolicited consultation: additional impact of a structured intervention on mortality in Staphylococcus aureus bacteraemia. J Antimicrob Chemother. 2019 Apr 1;74(4):1101-1107. doi: 10.1093/jac/dky556.
PubMed 30689894Smith JR, Frens JJ, Snider CB, Claeys KC. Impact of a pharmacist-driven care package on Staphylococcus aureus bacteremia management in a large community healthcare network: A propensity score-matched, quasi-experimental study. Diagn Microbiol Infect Dis. 2018 Jan;90(1):50-54. doi: 10.1016/j.diagmicrobio.2017.10.001. Epub 2017 Oct 7.
PubMed 29153470Goto M, Schweizer ML, Vaughan-Sarrazin MS, Perencevich EN, Livorsi DJ, Diekema DJ, Richardson KK, Beck BF, Alexander B, Ohl ME. Association of Evidence-Based Care Processes With Mortality in Staphylococcus aureus Bacteremia at Veterans Health Administration Hospitals, 2003-2014. JAMA Intern Med. 2017 Oct 1;177(10):1489-1497. doi: 10.1001/jamainternmed.2017.3958.
PubMed 28873140Wenzler E, Wang F, Goff DA, Prier B, Mellett J, Mangino JE, Bauer KA. An Automated, Pharmacist-Driven Initiative Improves Quality of Care for Staphylococcus aureus Bacteremia. Clin Infect Dis. 2017 Jul 15;65(2):194-200. doi: 10.1093/cid/cix315.
PubMed 28379326
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Antimicrobial Stewardship Recommendation Bundle for Staphylococcus Aureus Bloodstream Infections
- ClinicalTrials.gov ID
- NCT06211829
- Acronym / sponsor ID
- 016.PHA.2022.D
- Conditions
- Bacterial Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 18 Jan 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.
In July 2020, a bundle (Appendix C) was implemented at Methodist Dallas Medical Center where all patients with SAB were reviewed by the antimicrobial stewardship pharmacist (Monday - Friday from 0700 to 1500), a note outlining optimal interventions was written in the electronic medical record (EMR), and the recommendations were communicated to the primary team via secure messaging or telephone
Detailed description
Evaluation of the Staphylococcus aureus bloodstream infection(SAB)bundle recommendations will allow for determination of whether this intervention is impactful and warrants the resources currently devoted to it.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 18 years of age SAB during hospital admission a history of a prior SAB during the study period (only first occurrence
Key inclusion criteria (1 listed)
- 18 years of age SAB during hospital admission
Key exclusion criteria (4 listed)
- Patients with a history of a prior SAB during the study period (only first occurrence included)
- Blood culture collected within 48hours of patient expiring or transitioning to hospice
- Patients discharged or left before culture results were available
- Patients transferred from an outside hospital
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
number of Staphylococcus Aureus blood stream infections (SAB)
Time frame: 12 weeks
Number of SAB occurring
5 secondary outcomes
Number of In-hospital mortality
Time frame: 12 weeks
number of times of bacteremia
Time frame: 12 weeks
number of days of stay
Time frame: 12 weeks
number of times of readmission
Time frame: 12 weeks
number of infection
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Background: PubMed 30264119Holland TL, Raad I, Boucher HW, Anderson DJ, Cosgrove SE, Aycock PS, Baddley JW, Chaftari AM, Chow SC, Chu VH, Carugati M, Cook P, Corey GR, Crowley AL, Daly J, Gu J, Hachem R, Horton J, Jenkins TC, Levine D, Miro JM, Pericas JM, Riska P, Rubin Z, Rupp ME, Schrank J Jr, Sims M, Wray D, Zervos M, Fowler VG Jr; Staphylococcal Bacteremia Investigators. Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious Adverse Events in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial. JAMA. 2018 Sep 25;320(12):1249-1258. doi: 10.1001/jama.2018.13155.
- Background: PubMed 30689894Perez-Rodriguez MT, Sousa A, Lopez-Cortes LE, Martinez-Lamas L, Val N, Baroja A, Nodar A, Vasallo F, Alvarez-Fernandez M, Crespo M, Rodriguez-Bano J. Moving beyond unsolicited consultation: additional impact of a structured intervention on mortality in Staphylococcus aureus bacteraemia. J Antimicrob Chemother. 2019 Apr 1;74(4):1101-1107. doi: 10.1093/jac/dky556.
- Background: PubMed 29153470Smith JR, Frens JJ, Snider CB, Claeys KC. Impact of a pharmacist-driven care package on Staphylococcus aureus bacteremia management in a large community healthcare network: A propensity score-matched, quasi-experimental study. Diagn Microbiol Infect Dis. 2018 Jan;90(1):50-54. doi: 10.1016/j.diagmicrobio.2017.10.001. Epub 2017 Oct 7.
- Background: PubMed 28873140Goto M, Schweizer ML, Vaughan-Sarrazin MS, Perencevich EN, Livorsi DJ, Diekema DJ, Richardson KK, Beck BF, Alexander B, Ohl ME. Association of Evidence-Based Care Processes With Mortality in Staphylococcus aureus Bacteremia at Veterans Health Administration Hospitals, 2003-2014. JAMA Intern Med. 2017 Oct 1;177(10):1489-1497. doi: 10.1001/jamainternmed.2017.3958.
- Background: PubMed 28379326Wenzler E, Wang F, Goff DA, Prier B, Mellett J, Mangino JE, Bauer KA. An Automated, Pharmacist-Driven Initiative Improves Quality of Care for Staphylococcus aureus Bacteremia. Clin Infect Dis. 2017 Jul 15;65(2):194-200. doi: 10.1093/cid/cix315.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bacterial Infections, run by Methodist Health System at 1 site in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 6 Aug 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of Staphylococcus Aureus blood stream infections (SAB) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06211829, which also lists 5 linked publications.
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 6 Aug 2025.