Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures
研究概览
简要总结
The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.
详细描述
Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).
CA-MRSA has become a major source of morbidity and mortality in our pediatric population. An important prerequisite for S. aureus infection may be nasal carriage of the organism. A variety of decolonization strategies have been used for infection prophylaxis, primarily in patients undergoing hemodialysis or surgery, with varying results. However, there are no published randomized eradication trials evaluating the decolonization and prevention of CA-MRSA infections in immunocompetent children in the outpatient setting. While the transmission of CA-MRSA within households has been reported, its contribution to recurrent CA-MRSA infection among household members is undetermined. The investigators hypothesize that spread of CA-MRSA among household members leads to recolonization or failure of decolonization in children undergoing eradication efforts.
Specific Aim: In pediatric patients presenting with a MRSA skin or soft tissue infection, compare the effectiveness of decolonization measures performed by an entire household in comparison to measures directed at the index patient alone. The investigators will conduct a randomized, controlled trial to test the hypothesis that decolonization measures performed by the entire household, specifically application of intranasal mupirocin ointment and bathing with chlorhexidine liquid soap, in addition to education and basic hygiene interventions, will be twice as effective in eradicating CA-MRSA carriage in the index patient than if the measures are performed only by the index patient.
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
- 6 Months 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 months to 21 years presenting with an active skin or soft tissue infection.
- •Enrollment:
- •Positive MRSA culture from the abscess and from either the axilla, anterior nares or groin area (signifying both infection and colonization with MRSA).
排除标准
- •Infants less than 6 months of age
- •Dialysis or residence in a long term care facility over the past year
- •Use of chlorhexidine or mupirocin in the past one month
- •Pregnancy
- •Immunodeficiency
- •History of an adverse reaction to chlorhexidine or mupirocin.
研究组 & 干预措施
Index patient only
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
干预措施: 2% Mupirocin Ointment (Drug)
Index patient only
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
干预措施: 4% Chlorhexidine liquid soap (Drug)
Index patient only
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
干预措施: Hygiene protocol (Behavioral)
Household
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
干预措施: 2% Mupirocin Ointment (Drug)
Household
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
干预措施: 4% Chlorhexidine liquid soap (Drug)
Household
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
干预措施: Hygiene protocol (Behavioral)
结局指标
主要结局
Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures
时间窗: 1 month after enrollment.
Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient.
次要结局
- Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures(3 month after enrollment.)
- Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures(12 month after enrollment.)
- Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures(6 month after enrollment.)
- Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.(3 month after enrollment)
- Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.(6 month after enrollment)
- Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.(12 month after enrollment)
- Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.(1 month after enrollment)
研究者
Stephanie A. Fritz
Assistant Professor of Pediatrics
Washington University School of Medicine