Clinical Trials Directory

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

TypeNameDescription
DEVICEXpert MRSA/SA SSTIUse of Xpert MRSA/SA SSTI assay
DIAGNOSTIC_TESTStandard 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.