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

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.

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Abscess
• Intervention / Treatment: Device: Xpert MRSA/SA SSTI; 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.

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20037
      • The George Washington University
  • Maryland
    • Baltimore, Maryland, United States
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Antibiotic Usage at the Time of the ED Visit	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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Clinical Improvement Post-treatment at One Week	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	2 to 7 days
Clinical Outcome at One or Three Months	Recurrence of abscess within a three month time period	3 months

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Larissa S May, MD, The George Washington University

Publications and helpful links

General Publications

• May LS, Rothman RE, Miller LG, Brooks G, Zocchi M, Zatorski C, Dugas AF, Ware CE, Jordan JA. 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. Infect Control Hosp Epidemiol. 2015 Dec;36(12):1423-30. doi: 10.1017/ice.2015.202. Epub 2015 Aug 26.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: January 26, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: August 4, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: SSTI; cutaneous abscess; boil
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Disease Attributes; Suppuration; Emergencies; Abscess; Skin Diseases
• Other Study ID Numbers: 030927

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO