Randomized Trial of Trimethoprim-Sulfamethoxazole Versus Placebo Added to Standard Treatment of Uncomplicated Cellulitis in Emergency Department Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 3
- 主要终点
- Relative Efficacy
研究概览
简要总结
The primary aim of this study is to quantify the effectiveness of Bactrim as additional therapy for the treatment of uncomplicated cellulitis in adults, by comparing: standard therapy plus Bactrim, versus standard therapy plus placebo.
The primary hypothesis of this study is that, in light of increasing CA-MRSA prevalence, subjects treated with standard therapy plus Bactrim will have higher cure rates than those treated with standard therapy plus placebo.
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 (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Age < 12 months or weight <15 kg
- •Current skin infection has already been treated
- •Allergy to sulfa drugs
- •History of severe allergic reaction to penicillin (defined as anaphylactoid reaction, angioedema, bronchospasm)
- •Current use of any antibiotic (other than topicals)
- •Diabetes mellitus
- •Cellulitis complicated by underlying peripheral vascular disease
- •Renal insufficiency, defined as patient report, clinical suspicion, or creatinine>1.3 or EGFR<60 on the last-available set of chemistry results in our computer system
- •Hospital admission required
- •Presence of > 1 cc of purulent discharge at any time
- •Cellulitis involving an indwelling vascular, enteric, or urinary catheter
- •Immunocompromise of any etiology
- •Pregnancy
- •Breast feeding
- •Facial cellulitis (infection is above the clavicles)
- •Cellulitis associated with marine or freshwater injury, or animal or human bite. (Insect bites not excluded.)
- •History of glucose-6-phosphate dehydrogenase deficiency
- •Taking coumadin (warfarin), methotrexate, cisapride, phenytoin (dilantin), digoxin, or dofetilide
- •Known megaloblastic anemia due to folate deficiency.
研究组 & 干预措施
Standard therapy
cephalexin plus placebo
干预措施: Cephalexin (Drug)
Standard plus anti-CA-MRSA
cephalexin plus trimethoprim-sulfamethoxazole
干预措施: trimethoprim-sulfamethoxazole (Drug)
Standard plus anti-CA-MRSA
cephalexin plus trimethoprim-sulfamethoxazole
干预措施: Cephalexin (Drug)
结局指标
主要结局
Relative Efficacy
时间窗: 12 +/- 2 days; 30 +/- 2 days
Proportion of subjects in each arm with successful treatment. Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days.
次要结局
- Progression to Abscess(12 +/- 2 days, 30 days +/- 2 days)
研究者
Daniel Jay Pallin, MD, MPH
Associate Research Director, Department of Emergency Medicine
Brigham and Women's Hospital