- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06211829
An Evaluation of a Antimicrobial Stewardship Recommendation Bundle for Staphylococcus Aureus Bloodstream Infections
January 16, 2024 updated by: Methodist Health System
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
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
208
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
-
Dallas, Texas, United States, 75203
- Methodist Dallas Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
18 years of age SAB during hospital admission a history of a prior SAB during the study period (only first occurrence
Description
Inclusion Criteria:
- 18 years of age SAB during hospital admission
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of Staphylococcus Aureus blood stream infections (SAB)
Time Frame: 12 weeks
|
Number of SAB occurring
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of In-hospital mortality
Time Frame: 12 weeks
|
Number of In-hospital mortality
|
12 weeks
|
number of times of bacteremia
Time Frame: 12 weeks
|
time of bacteremia
|
12 weeks
|
number of days of stay
Time Frame: 12 weeks
|
duration of hospital stay
|
12 weeks
|
number of times of readmission
Time Frame: 12 weeks
|
Number time of readmission
|
12 weeks
|
number of infection
Time Frame: 12 weeks
|
Number of times the infection is occurring
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Goto 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. Erratum In: JAMA Intern Med. 2017 Oct 1;177(10):1544.
- 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.
- Perez-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.
- Smith 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.
- Wenzler 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2022
Primary Completion (Estimated)
May 18, 2024
Study Completion (Estimated)
May 18, 2024
Study Registration Dates
First Submitted
July 6, 2023
First Submitted That Met QC Criteria
January 16, 2024
First Posted (Estimated)
January 18, 2024
Study Record Updates
Last Update Posted (Estimated)
January 18, 2024
Last Update Submitted That Met QC Criteria
January 16, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 016.PHA.2022.D
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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