Skip to main content
OpenTrials
Completed

NCT Number: NCT01523899

Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cutaneous Abscess Animal Diseases Bacterial Infections Bacterial Infections and Mycoses Fish Diseases Furunculosis Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The George Washington University, Washington D.C., District of Columbia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xpert MRSA/SA SSTI

Device

Use of Xpert MRSA/SA SSTI assay

Standard culture

Diagnostic Test

Primary outcomes

  1. Number of Participants With Antibiotic Usage at the Time of the ED Visit

    Time frame: Baseline

    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 outcomes

  1. Participant Clinical Improvement Post-treatment at One Week

    Time frame: 2 to 7 days

    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. Clinical Outcome at One or Three Months

    Time frame: 3 months

    Recurrence of abscess within a three month time period

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2012
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.