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

This study has been completed.
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Larissa May, George Washington University
ClinicalTrials.gov Identifier:
NCT01523899
First received: January 26, 2012
Last updated: March 9, 2015
Last verified: March 2015
  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 Phase
Cutaneous Abscess
Device: Xpert MRSA/SA SSTI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Further study details as provided by George Washington University:

Primary Outcome Measures:
  • antibiotic usage [ Time Frame: 0 days ] [ Designated as safety issue: No ]
    antibiotic use (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit


Secondary Outcome Measures:
  • clinical improvement [ Time Frame: 2 to 7 days ] [ Designated as safety issue: No ]
    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


Enrollment: 272
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 Device: Xpert MRSA/SA SSTI
Use of Xpert MRSA/SA SSTI assay
Standard culture Device: Xpert MRSA/SA SSTI
Use of Xpert MRSA/SA SSTI assay

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523899

Locations
United States, District of Columbia
The George Washington University
Washington, 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

No publications provided

Responsible Party: Larissa May, Assistant Professor of Emergency Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT01523899     History of Changes
Other Study ID Numbers: 030927
Study First Received: January 26, 2012
Last Updated: March 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
SSTI
cutaneous abscess
boil

Additional relevant MeSH terms:
Abscess
Infection
Inflammation
Pathologic Processes
Suppuration

ClinicalTrials.gov processed this record on May 29, 2015