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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Number of Participants With Antibiotic Usage at the Time of the ED Visit
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 years or older with community onset abscess
排除标准
- •previous treatment for same abscess in past 14 days
- •postoperative infection
- •inability to provide informed consent
研究组 & 干预措施
Xpert MRSA/SA SSTI
use of the Xpert MRSA/SSTI diagnostic assay
干预措施: Xpert MRSA/SA SSTI (Device)
Standard culture
performance of standard bacterial culture of abscess material
干预措施: Standard culture (Diagnostic Test)
结局指标
主要结局
Number of Participants With Antibiotic Usage at the Time of the ED Visit
时间窗: 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
次要结局
- Participant Clinical Improvement Post-treatment at One Week(2 to 7 days)
- Clinical Outcome at One or Three Months(3 months)
研究者
Larissa May
Assistant Professor of Emergency Medicine
George Washington University