Clinical trial NCT01523899: Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cutaneous Abscess
Keywords: SSTI
cutaneous abscess
boil
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2012-02-01
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Participants With Antibiotic Usage at the Time of the ED Visit
timeFrame: Baseline
Secondary outcomes:
measure: Participant Clinical Improvement Post-treatment at One Week
timeFrame: 2 to 7 days
measure: Clinical Outcome at One or Three Months
timeFrame: 3 months
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: The George Washington University
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: The George Washington University
name: Larissa S May, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.