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

NCT ID: NCT01523899

Last Updated: 2017-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-01-31

Brief 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

Cutaneous Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Xpert MRSA/SA SSTI

use of the Xpert MRSA/SSTI diagnostic assay

Group Type: EXPERIMENTAL

Xpert MRSA/SA SSTI

Intervention Type: DEVICE

Use of Xpert MRSA/SA SSTI assay

Standard culture

performance of standard bacterial culture of abscess material

Group Type: ACTIVE_COMPARATOR

Standard culture

Intervention Type: DIAGNOSTIC_TEST

Interventions

Xpert MRSA/SA SSTI

Use of Xpert MRSA/SA SSTI assay

Intervention Type: DEVICE

Standard culture

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Larissa May

Assistant Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larissa S May, MD

Role: PRINCIPAL_INVESTIGATOR

The George Washington University

Locations

The George Washington University

Washington D.C., District of Columbia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

References

May LS, Rothman RE, Miller LG, Brooks G, Zocchi M, Zatorski C, Dugas AF, Ware CE, Jordan JA. 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. Infect Control Hosp Epidemiol. 2015 Dec;36(12):1423-30. doi: 10.1017/ice.2015.202. Epub 2015 Aug 26.

Reference Type: DERIVED

PMID: 26306996 (View on PubMed)

Other Identifiers

030927

Identifier Type: -

Identifier Source: org_study_id