Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses
This study is currently recruiting participants.
Verified March 2013 by George Washington University
Sponsor:
George Washington University
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Larissa May, George Washington University
ClinicalTrials.gov Identifier:
NCT01523899
First received: January 26, 2012
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cutaneous Abscess |
Device: Xpert MRSA/SA SSTI |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
Further study details as provided by George Washington University:
Primary Outcome Measures:
- antibiotic usage [ Time Frame: 0 days ] [ Designated as safety issue: No ]antibiotic use (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit
Secondary Outcome Measures:
- clinical improvement [ Time Frame: 2 to 7 days ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 250 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Xpert MRSA/SA SSTI |
Device: Xpert MRSA/SA SSTI
Use of Xpert MRSA/SA SSTI assay
|
| Standard culture |
Device: Xpert MRSA/SA SSTI
Use of Xpert MRSA/SA SSTI assay
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523899
Locations
| United States, District of Columbia | |
| The George Washington University | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Larissa May 202-741-2923 larissa@gwu.edu | |
| Principal Investigator: Larissa May, MD, MS | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States | |
| Contact: Andrea Dugas adugas1@jhmi.edu | |
| Sub-Investigator: Andrea Dugas | |
| Principal Investigator: Richard Rothman, MD, PhD | |
Sponsors and Collaborators
George Washington University
Johns Hopkins University
Investigators
| Principal Investigator: | Larissa S May, MD | The George Washington University |
More Information
No publications provided
| Responsible Party: | Larissa May, Assistant Professor of Emergency Medicine, George Washington University |
| ClinicalTrials.gov Identifier: | NCT01523899 History of Changes |
| Other Study ID Numbers: | 030927 |
| Study First Received: | January 26, 2012 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by George Washington University:
|
SSTI cutaneous abscess boil |
Additional relevant MeSH terms:
|
Abscess Skin Diseases Suppuration |
Infection Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013