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Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01523899
First Posted: February 1, 2012
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Larissa May, George Washington University
  Purpose
This study expands upon pilot data for feasibility since May 2011. The study aims to evaluate the effect of rapid test availability on use of targeted spectrum antibiotics for non-MRSA abscesses in ambulatory patients in the Emergency Department (ED). The multi-institutional study will assess the feasibility of providing the GeneXpert® MRSA/SA SSTI assay to the ED and evaluate the impact of delivering the test result to clinicians in real-time on patient management decisions regarding the use of antimicrobial agents. Patients are randomized to standard culture (control arm) or to the GeneXpert® assay plus standard culture.

Condition Intervention
Cutaneous Abscess Device: Xpert MRSA/SA SSTI Diagnostic Test: Standard culture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Clinical Trial Comparing Use of Rapid Molecular Testing for Staphylococcus Aureus for Patients With Cutaneous Abscesses in the Emergency Department With Standard of Care.

Resource links provided by NLM:


Further study details as provided by Larissa May, George Washington University:

Primary Outcome Measures:
  • Number of Participants With Antibiotic Usage at the Time of the ED Visit [ Time Frame: Baseline ]
    Number of Participants with Antibiotic Usage at the time of the ED visit (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit


Secondary Outcome Measures:
  • Participant Clinical Improvement Post-treatment at One Week [ Time Frame: 2 to 7 days ]
    clinical improvement (decreasing erythema, pain, swelling, drainage, and presence or absence of fever) will be documented at 2-7 day phone follow up and 1 and 3 months

  • Clinical Outcome at One or Three Months [ Time Frame: 3 months ]
    Recurrence of abscess within a three month time period


Enrollment: 252
Study Start Date: May 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xpert MRSA/SA SSTI
use of the Xpert MRSA/SSTI diagnostic assay
Device: Xpert MRSA/SA SSTI
Use of Xpert MRSA/SA SSTI assay
Active Comparator: Standard culture
performance of standard bacterial culture of abscess material
Diagnostic Test: Standard culture

Detailed Description:

Our objective was to determine whether real-time availability of rapid molecular results of Staphylococcus aureus would impact emergency department clinician antimicrobial selection for adults with cutaneous abscesses.

We performed a prospective, randomized controlled trial in two urban emergency departments comparing a rapid molecular test with standard of care culture-based testing. Follow-up telephone calls were made at between 2 and 7 days, 1 month, and 3 months after discharge.

Patients at least 18 years old presenting with a chief complaint of abscess, cellulitis, or insect bite and receiving incision and drainage were eligible. Seven hundred seventy-eight people were assessed for eligibility and 252 met eligibility criteria.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults 18 years or older with community onset abscess

Exclusion Criteria:

  • previous treatment for same abscess in past 14 days
  • postoperative infection
  • inability to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523899


Locations
United States, District of Columbia
The George Washington University
Washington, D.C., District of Columbia, United States, 20037
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
Sponsors and Collaborators
George Washington University
Johns Hopkins University
Investigators
Principal Investigator: Larissa S May, MD The George Washington University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Larissa May, Assistant Professor of Emergency Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT01523899     History of Changes
Other Study ID Numbers: 030927
First Submitted: January 26, 2012
First Posted: February 1, 2012
Results First Submitted: February 23, 2017
Results First Posted: September 6, 2017
Last Update Posted: September 6, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Larissa May, George Washington University:
SSTI
cutaneous abscess
boil

Additional relevant MeSH terms:
Emergencies
Abscess
Skin Diseases
Disease Attributes
Pathologic Processes
Suppuration
Infection
Inflammation