Prevention of Recurrent Infections Caused by Community-Acquired Staphylococcus in Children 3 Months to 18 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 987
- 试验地点
- 4
- 主要终点
- Medically Attended Skin and Soft Tissue Infections (MA-SSI)
研究概览
简要总结
The primary purpose of this study is to determine if adding bleach baths to routine ways for prevention of Staph infections is helpful. The amount added is a very weak amount. This would provide a relatively inexpensive method to help prevent recurrent skin infections caused by the Staph germ. The investigators will also be studying how often Staphylococcus aureus lives in the nose, throat, and groin area.
详细描述
In many areas of the United States, methicillin-resistant Staphylococcus aureus is now an established community pathogen (CA-MRSA). At Texas Children's Hospital (TCH), about 75% of S. aureus isolates recovered from healthy children with infections are CA-MRSA and > 90% of the CA-MRSA isolates are related to one clone, USA300, which also predominates throughout the U.S. From 8/05 to 7/06, 1400 children with CA-MRSA infection were seen at TCH; 60% were admitted to the hospital. Why the USA300 clone is so successful in spreading throughout the community is unclear, but it does harbor a unique set of genes not found in other S. aureus clones. The anterior nose in the most common area of the body colonized with S. aureus but it is not known if this is the primary site for colonization by CA-MRSA USA300 clone.
Approximately 3.5% of children at TCH have a proven recurrence of S. aureus infection within 12 months; we believe this is a minimal estimate and that overall at least 10% of children have recurrences. There is no consensus on the best strategies for preventing recurrent S. aureus infections or spread of S. aureus among family members. At TCH, in addition to routine preventative measures, we often recommend for the patients to take a bath at least twice a week in water to which one teaspoon of household bleach (Clorox) has been added per gallon of water. Anecdotally this approach has decreased the recurrence rate of S. aureus infections, but this common strategy among dermatologists has not been formally evaluated and is thus controversial.
Objectives
The primary objective is to test the hypothesis that in children who have a community-acquired Staphylococcus aureus (CA-SA) infection, sodium hypochlorite baths (Clorox) are a safe and effective component of a prevention strategy that will reduce recurrent medically attended skin and soft tissue infection (MA-SSI).
Specific Aims
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy children 3 months to 18 years seen in the emergency center of Texas Children's Hospital with suspected CA-S. aureus infections
- •Have a lesion which can be cultured (abscess or cellulitis with drainage, invasive infections)
- •Can be evaluated and treated in the emergency center and be followed as outpatients
- •Can be admitted to the hospital
排除标准
- •Children less than 3 months old or greater than 18 years
- •Immune deficiency or underlying condition other than reactive airway disease or simple eczema which is not being followed by a dermatologist
- •Patient has a history of 2 or more previous skin or soft tissue infections
- •Children with one previous episode whose family may have already employed the sodium hypochlorite baths
- •Families without a bathtub or running water
- •Families without a phone or primary care physician
- •Families unable or unwilling to comply with the prevention measures
- •Hypersensitivity to sodium hypochlorite
结局指标
主要结局
Medically Attended Skin and Soft Tissue Infections (MA-SSI)
时间窗: From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.
Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting.
次要结局
未报告次要终点
研究者
Sheldon Kaplan
Professor of Pediatrics
Baylor College of Medicine