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临床试验/NCT00266448
NCT00266448已完成2 期

The Value of Whole Body Washing With Chlorhexidine for the Eradication of MRSA - a Randomized, Placebo-Controlled, Double-Blinded Clinical Trial

Heidelberg University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2001年1月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
100
试验地点
2
主要终点
efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage

研究概览

简要总结

The purpose of this study is to determine whether whole body washing with chlorhexidine in combination with mupirocine nasal ointment is effective in the eradication of meticillin-resistant Staphylococcus aureus (MRSA).

详细描述

The number and rate of infections due to meticillin-resistant Staphylococcus aureus (MRSA)is increasing world wide. Patients who are colonized with MRSA are the main source for further distribution. In addition colonization with MRSA is a precondition for infection.

Whole body washing with antiseptic solutions as part of eradication strategies for MRSA has been widely used. However, there is insufficient evidence to support use of topical antimicrobial therapy for eradicating of MRSA because treatment with antiseptic solution has never been compared to placebo.

Comparison: The efficacy of whole body washing in the control of MRSA was studied in a randomized, placebo-controlled, double-blinded clinical trial. The study treatment consisted of five days of whole body washing either with 4% chlorhexidine solution (verum) or with placebo. All patients received mupirocin nasal ointment and chlorhexidine mouth rinse. The outcome was evaluated 3, 4, 5, 9 and 30 days after treatment by swabs taken from several body site.

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
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • persons who are colonized with MRSA, i.e. one or more cultures from any body site yielded MRSA

排除标准

  • ongoing systemic or local antimicrobial treatment directed against MRSA
  • hypersensitivity to mupirocin or chlorhexidine
  • pregnancy
  • previous enrolment

结局指标

主要结局

efficacy of a whole body treatment with chlorhexidine in eradicating overall MRSA carriage

次要结局

  • development of MRSA infection
  • tolerance to the antiseptic whole body treatment

研究者

申办方类型
Other

研究点 (2)

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