NCT01523899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 6, 2017

Completed
Last Updated

September 6, 2017

Status Verified

August 1, 2017

Enrollment Period

3.7 years

First QC Date

January 26, 2012

Results QC Date

February 23, 2017

Last Update Submit

August 4, 2017

Conditions

Cutaneous Abscess

Keywords

SSTIcutaneous abscessboil

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Antibiotic Usage at the Time of the ED Visit

    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

    Baseline

Secondary Outcomes (2)

  • Participant Clinical Improvement Post-treatment at One Week

    2 to 7 days

  • Clinical Outcome at One or Three Months

    3 months

Study Arms (2)

Xpert MRSA/SA SSTI

EXPERIMENTAL

use of the Xpert MRSA/SSTI diagnostic assay

Device: Xpert MRSA/SA SSTI

Standard culture

ACTIVE COMPARATOR

performance of standard bacterial culture of abscess material

Diagnostic Test: Standard culture

Interventions

Xpert MRSA/SA SSTIDEVICE

Use of Xpert MRSA/SA SSTI assay

Xpert MRSA/SA SSTI
Standard cultureDIAGNOSTIC_TEST
Standard culture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults 18 years or older with community onset abscess

You may not qualify if:

  • previous treatment for same abscess in past 14 days
  • postoperative infection
  • inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Johns Hopkins University

Baltimore, Maryland, United States

Location

Related Publications (1)

  • 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.

    PMID: 26306996DERIVED

MeSH Terms

Conditions

Furunculosis

Condition Hierarchy (Ancestors)

Staphylococcal Skin InfectionsStaphylococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesFish DiseasesAnimal Diseases

Results Point of Contact

Title
Larissa May, MD
Organization
University of California-Davis
lsmay@ucdavis.edu
9167345000

Study Officials

  • Larissa S May, MD

    The George Washington University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine

Study Record Dates

First Submitted

January 26, 2012

First Posted

February 1, 2012

Study Start

May 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 6, 2017

Results First Posted

September 6, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)