Randomized Placebo-Controlled Trial of Bactrim on 7 Day Outcome in Emergency Department Patients With Uncomplicated Abscesses at Risk for Community Acquired Methicillin Resistant Staph Aureus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Treatment Failures at 7 Days
研究概览
简要总结
Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria include all patients age 16 and older who present to the emergency department with a skin abscess that requires incision and drainage.
排除标准
- •Exclusion criteria include patients with diabetes, HIV, cancer or other immunocompromised patients.
- •Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
- •Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
- •Patients with abscesses on face, perirectal, or perianal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
- •Patients with fever or evidence of systemic infection
- •Finally, patients with sulfa allergy will be excluded.
研究组 & 干预措施
Matched placebo 2 pills po BID x 7 days
placebo
干预措施: placebo (Drug)
bactrim DS (800/160) 2 pills po BID x 7 days
active comparator
干预措施: bactrim (Drug)
结局指标
主要结局
Treatment Failures at 7 Days
时间窗: 7 days
worsening abscess or new recurrence of abscess
次要结局
未报告次要终点