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

Not Applicable

Completed

• Conditions: Cutaneous Abscess
• Interventions: Diagnostic Test: Standard culture; Device: Xpert MRSA/SA SSTI

• Registration Number: NCT01523899
• Lead Sponsor: George Washington University

Brief Summary

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.

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2017-02-23
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-04
• Last Update Submitted: 2017-08-04
• Results First Posted: 2017-09-06
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard culture	Standard culture	performance of standard bacterial culture of abscess material
Xpert MRSA/SA SSTI	Xpert MRSA/SA SSTI	use of the Xpert MRSA/SSTI diagnostic assay

Primary Outcome Measures

Name	Time	Method
Number of Participants With Antibiotic Usage at the Time of the ED Visit	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

Name	Time	Method
Participant Clinical Improvement Post-treatment at One Week	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	3 months	Recurrence of abscess within a three month time period

Trial Locations

Locations (2)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

The George Washington University; 🇺🇸 Washington, D.C., District of Columbia, United States