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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06211829
Other study ID # 016.PHA.2022.D
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 18, 2022
Est. completion date May 18, 2024

Study information

Verified date January 2024
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 recommendations were communicated to the primary team via secure messaging or telephone


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 208
Est. completion date May 18, 2024
Est. primary completion date May 18, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Locations

Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary number of Staphylococcus Aureus blood stream infections (SAB) Number of SAB occurring 12 weeks
Secondary Number of In-hospital mortality Number of In-hospital mortality 12 weeks
Secondary number of times of bacteremia time of bacteremia 12 weeks
Secondary number of days of stay duration of hospital stay 12 weeks
Secondary number of times of readmission Number time of readmission 12 weeks
Secondary number of infection Number of times the infection is occurring 12 weeks
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