Randomized Non-inferiority Trial of 3 Versus 10 Days of Trimethoprim-Sulfamethoxazole in Community-Associated Skin Abscesses After Surgical Drainage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Treatment Failures
研究概览
简要总结
The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.
详细描述
Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).
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
- None
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter)
- •minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient
排除标准
- •patients requiring immediate hospitalization
- •patients who have received 2 or more doses of antibiotics in the previous 36 hours
- •patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices
- •patients with a concurrent, non-abscess infection
- •patients with an allergy to Trimethoprim-sulfamethoxazole
研究组 & 干预措施
3 days of Trimethoprim-Sulfamethoxazole
Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
干预措施: Trimethoprim-Sulfamethoxazole (Drug)
10 days of Trimethoprim-Sulfamethoxazole
Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
干预措施: Trimethoprim-Sulfamethoxazole (Drug)
结局指标
主要结局
Treatment Failures
时间窗: up to 2 weeks after surgical drainage
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus
时间窗: up to 2 weeks after surgical drainage
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus
时间窗: up to 2 weeks after surgical drainage
Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.
次要结局
- Recurrent Skin Infections(1 month after surgical drainage)
- Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus(1 month after surgical drainage)
- Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus(1 month after surgical drainage)
研究者
Lucy Holmes, MD
Clinical Associate Professor of Pediatrics
State University of New York at Buffalo