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

Cutaneous Abscess Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523899
• Other study ID #: 030927
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2012
• Last updated: March 9, 2015
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Abscess
• Cutaneous Abscess

Intervention

Device:
• Xpert MRSA/SA SSTI
Use of Xpert MRSA/SA SSTI assay

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	The George Washington University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antibiotic usage	antibiotic use (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit	0 days	No
Secondary	clinical improvement	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	No