Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Clinical Improvement at 7 Days After Incision and Drainage
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)no antibiotic or 2) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all patients age 18-55 who present to the emergency department with a skin abscess that requires incision and drainage.
排除标准
- •patients with diabetes, HIV, cancer or other immunocompromised patients
- •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
- •basic Military Trainees will also be excluded from participation
- •patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded
- •patients with sulfa allergy will be excluded.
研究组 & 干预措施
Septra DS
Septra DS (800/160) two pills PO BID x 7 days
干预措施: Septra (Drug)
结局指标
主要结局
Clinical Improvement at 7 Days After Incision and Drainage
时间窗: 7 days
improving wound without evidence of fever, worsening cellulitis or induration
次要结局
- Recurrence Rates(30 days)