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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01523899
Other study ID # 030927
Secondary ID
Status Completed
Phase Phase 4
First received January 26, 2012
Last updated March 9, 2015
Start date May 2011
Est. completion date January 2015

Study information

Verified date March 2015
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Device:
Xpert MRSA/SA SSTI
Use of Xpert MRSA/SA SSTI assay

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States The George Washington University Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
George Washington University Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary antibiotic usage antibiotic use (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit 0 days No
Secondary clinical improvement 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 No
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