Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by George Washington University
Johns Hopkins University
Information provided by (Responsible Party):
Larissa May, George Washington University Identifier:
First received: January 26, 2012
Last updated: January 22, 2014
Last verified: January 2014

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

Estimated Enrollment: 250
Study Start Date: May 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01523899

United States, District of Columbia
The George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Larissa May    202-741-2923   
Principal Investigator: Larissa May, MD, MS         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States
Contact: Andrea Dugas   
Sub-Investigator: Andrea Dugas         
Principal Investigator: Richard Rothman, MD, PhD         
Sponsors and Collaborators
George Washington University
Johns Hopkins University
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 Identifier: NCT01523899     History of Changes
Other Study ID Numbers: 030927
Study First Received: January 26, 2012
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
cutaneous abscess
boil processed this record on March 03, 2015