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临床试验/NCT01814371
NCT01814371已完成不适用

Individualized vs. Household Eradication of MRSA in Households With Children

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 474 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
474
试验地点
1
主要终点
Number of Participants With Incidence of SSTI at 3 Months After Decolonization

研究概览

简要总结

The purpose of this research study is to compare the effectiveness of commonly used decolonization treatments (application of mupirocin antibiotic ointment to the nose and bleach baths) when performed by individuals with a history of skin and soft tissue infection (SSTI) in the prior year (individualized approach) in comparison to decolonization of all household members (household approach) in an attempt to prevent Staphylococcus aureus skin infections. The investigators hypothesize an individualized decolonization approach will be equally as effective as a household approach to prevent SSTI.

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).

There is no available vaccine against S. aureus. Thus, other preventive measures, including topical antimicrobial therapies, have been used in an attempt to prevent staphylococcal infections. These therapies include mupirocin (a topical antibiotic with activity against MRSA) and dilute bleach water baths. The effectiveness of these measures directed at patients colonized with traditional MSSA and HA-MRSA strains in an attempt to prevent nosocomial infections varies across studies, and maintenance of eradication diminishes over time. With the emergence of the CA-MRSA epidemic, these measures have been extrapolated to patients in community settings. We aim to find a practical approach to decolonization which patients can feasibly perform at home to reduce the incidence of skin and soft tissue infections(SSTI).

Specific Aim: Compare the effectiveness of decolonization of individuals with a history of SSTI in the prior year (individualized approach) to decolonization of all household members (household approach) in reducing the incidence of recurrent SSTI. Primary hypothesis: An individualized decolonization approach will be equally as effective as decolonization of all household members to prevent SSTI. Secondary hypothesis: Application of mupirocin to the anterior nares twice daily for 5 days will not result in a higher prevalence of colonization with mupirocin-resistant strains at subsequent longitudinal samplings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals who are enrolled in a 12-month observational study entitled "The Community-Associated Methicillin-Resistant Staphylococcus aureus Among Household Members and the Home Environment Study."

排除标准

  • Households in which all members experienced SSTI during the 12-month observational study
  • Individuals with known allergies to mupirocin or bleach (sodium hypochlorite)

研究组 & 干预措施

Individualized Approach

Active Comparator

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

干预措施: 2% mupirocin ointment (Drug)

Individualized Approach

Active Comparator

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

干预措施: Bleach Bath (dilute) (Other)

Individualized Approach

Active Comparator

The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year.

干预措施: Hygiene Protocol (Behavioral)

Household Approach

Active Comparator

All members of the household will perform the decolonization regimen.

干预措施: 2% mupirocin ointment (Drug)

Household Approach

Active Comparator

All members of the household will perform the decolonization regimen.

干预措施: Bleach Bath (dilute) (Other)

Household Approach

Active Comparator

All members of the household will perform the decolonization regimen.

干预措施: Hygiene Protocol (Behavioral)

结局指标

主要结局

Number of Participants With Incidence of SSTI at 3 Months After Decolonization

时间窗: 3 months after enrollment

Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol

次要结局

  • Number of Participants Colonized With MRSA at 6 Months After Decolonization(6 months after enrollment)
  • Number of Participants Colonized With MRSA at 3 Months After Decolonization(3 months after enrollment)
  • Number of Participants Colonized With MRSA at 12 Months After Decolonization(12 months after enrollment)
  • Number of Participants With Incidence of SSTI at 9 Months After Decolonization(9 months after enrollment)
  • Number of Participants With Incidence of SSTI at 12 Months After Decolonization(12 months after enrollment)
  • Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.(1 Year)
  • Number of Participants Colonized With MRSA at 1 Month After Decolonization(1 month after enrollment)
  • Number of Participants Colonized With MRSA at 9 Months After Decolonization(9 months after enrollment)
  • Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance(1 month)
  • Number of Participants Adhering to Decolonization Measures(1 week)
  • Number of Participants With Incidence of SSTI at 1 Month After Decolonization(1 month after enrollment)
  • Number of Participants With Incidence of SSTI at 6 Months After Decolonization(6 months after enrollment)
  • Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period(1 week after enrollment)
  • Number of Participants Incurring Economic Burden of Performing Protocol(1 month after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie A. Fritz

Assistant Professor of Pediatrics

Washington University School of Medicine

研究点 (1)

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