Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses
Primary Purpose
Cutaneous Abscess
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xpert MRSA/SA SSTI
Standard culture
Sponsored by
About this trial
This is an interventional health services research trial for Cutaneous Abscess focused on measuring SSTI, cutaneous abscess, boil
Eligibility Criteria
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
Sites / Locations
- The George Washington University
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Xpert MRSA/SA SSTI
Standard culture
Arm Description
use of the Xpert MRSA/SSTI diagnostic assay
performance of standard bacterial culture of abscess material
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Clinical Outcome at One or Three Months
Recurrence of abscess within a three month time period
Full Information
NCT ID
NCT01523899
First Posted
January 26, 2012
Last Updated
August 4, 2017
Sponsor
George Washington University
Collaborators
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01523899
Brief Title
Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Abscess
Keywords
SSTI, cutaneous abscess, boil
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xpert MRSA/SA SSTI
Arm Type
Experimental
Arm Description
use of the Xpert MRSA/SSTI diagnostic assay
Arm Title
Standard culture
Arm Type
Active Comparator
Arm Description
performance of standard bacterial culture of abscess material
Intervention Type
Device
Intervention Name(s)
Xpert MRSA/SA SSTI
Intervention Description
Use of Xpert MRSA/SA SSTI assay
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard culture
Primary Outcome Measure Information:
Title
Number of Participants With Antibiotic Usage at the Time of the ED Visit
Description
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
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Participant Clinical Improvement Post-treatment at One Week
Description
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
Time Frame
2 to 7 days
Title
Clinical Outcome at One or Three Months
Description
Recurrence of abscess within a three month time period
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa S May, MD
Organizational Affiliation
The George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The George Washington University
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26306996
Citation
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.
Results Reference
derived
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Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses
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