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临床试验/NCT00513799
NCT00513799已完成不适用

The Natural History of Community-Associated Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections and an Evaluation of Decolonization Strategies

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007年3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
300
试验地点
2
主要终点
Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention

研究概览

简要总结

The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus.

In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.

详细描述

Infections with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) range in severity from superficial skin abscesses to invasive soft tissue infections like cellulitis and pyomyositis. There has been a large increase in the number of patients presenting to our institution with CA-MRSA infections. Colonization with S. aureus (SA) may be linked to the development of infection but data on this phenomenon are limited. The recurrence rate for CA-MRSA soft tissue infections is unknown. A variety of decolonization strategies have been used for infection prophylaxis with varying results, primarily in patients undergoing hemodialysis or surgery. This study seeks to determine the recurrence rate of soft tissue infections among patients with CA-MRSA infections and to determine a reasonable and efficacious decolonization strategy to eradicate CA-MRSA from previously infected patients.

The proposed methods for decolonization will be tested in a randomized controlled trial with four intervention arms. The intervention arms are: (1) intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group"), (2) application of mupirocin in the nasal mucosa alone, (3) a combination of nasal application of mupirocin and chlorhexidine showers, and (4) a combination of nasal application of mupirocin and bathing in dilute bleach water. The "control" group as well as the three other arms will receive intensive hygiene education.

Decolonization with mupirocin ointment and chlorhexidine showers or dilute bleach baths in combination are likely to be more successful than either the application of nasal mupirocin ointment alone or hygiene measures alone. It is expected that these decolonization methods will result in a 50% relative reduction in MRSA colonization at 6 months.

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 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient who presents with at least one serious skin or soft tissue infection requiring incision and drainage at an affiliated institution or clinic in the St. Louis metropolitan area

排除标准

  • Patients with permanent indwelling catheters or percutaneous medical devices
  • Patients with a history of dialysis treatments, long term care facility admission, or presents with a surgical wound infection within the past year
  • Patients who are pregnant

研究组 & 干预措施

1: Hygiene Education

Active Comparator

Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")

干预措施: Intensive education on personal hygiene (Behavioral)

2: Hygiene education + mupirocin

Active Comparator

Application of mupirocin in the nasal mucosa alone

干预措施: Mupirocin ointment (Drug)

2: Hygiene education + mupirocin

Active Comparator

Application of mupirocin in the nasal mucosa alone

干预措施: Intensive education on personal hygiene (Behavioral)

Education + mupirocin + chlorhexidine

Active Comparator

A combination of nasal application of mupirocin and chlorhexidine showers

干预措施: Mupirocin ointment (Drug)

Education + mupirocin + chlorhexidine

Active Comparator

A combination of nasal application of mupirocin and chlorhexidine showers

干预措施: Chlorhexidine showers (Genetic)

Education + mupirocin + chlorhexidine

Active Comparator

A combination of nasal application of mupirocin and chlorhexidine showers

干预措施: Intensive education on personal hygiene (Behavioral)

4: Education + mupirocin + bleach baths

Active Comparator

A combination of nasal application of mupirocin and bathing in dilute bleach water

干预措施: Mupirocin ointment (Drug)

4: Education + mupirocin + bleach baths

Active Comparator

A combination of nasal application of mupirocin and bathing in dilute bleach water

干预措施: Bleach baths (dilute) (Procedure)

4: Education + mupirocin + bleach baths

Active Comparator

A combination of nasal application of mupirocin and bathing in dilute bleach water

干预措施: Intensive education on personal hygiene (Behavioral)

结局指标

主要结局

Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention

时间窗: 1 month follow-up

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. Samples obtained by study team at follow-up visit.

次要结局

  • Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention(4 month follow-up)
  • Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection(1, 4 and 6 month follow-ups)

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 (2)

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