Trials / Completed
CompletedNCT01523899
Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 252 (actual)
- Sponsor
- George Washington University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Xpert MRSA/SA SSTI | Use of Xpert MRSA/SA SSTI assay |
| DIAGNOSTIC_TEST | Standard culture |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2012-02-01
- Last updated
- 2017-09-06
- Results posted
- 2017-09-06
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01523899. Inclusion in this directory is not an endorsement.