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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Cutaneous Abscess

Intervention / Treatment
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* Device: Xpert MRSA/SA SSTI
* Diagnostic Test: Standard culture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xpert MRSA/SA SSTI<br>use of the Xpert MRSA/SSTI diagnostic assay | Device: Xpert MRSA/SA SSTI<br>* Use of Xpert MRSA/SA SSTI assay<br>|
| Active Comparator: Standard culture<br>performance of standard bacterial culture of abscess material | Diagnostic Test: Standard culture<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SSTI, cutaneous abscess, boil