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临床试验/NCT01049438
NCT01049438已完成不适用

A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections

Natividad Medical Center0 个研究点目标入组 31 人开始时间: 2006年8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
31
主要终点
A new MRSA or skin infection consistent with MRSA infection.

研究概览

简要总结

This clinical trial tests the hypothesis that body decolonization of patients with recurrent community-associated (CA) MRSA infections will significantly reduce the likelihood of recurrent CA-MRSA infection.

详细描述

Staphylococcus aureus is a ubiquitous pathogen, and causes infections of the skin, lung, bloodstream, and other body parts. Over the past decade,community-acquired methicillin resistant S. aureus (CA-MRSA) infections, which were previously extremely rare, are occurring commonly worldwide. CA-MRSA is the most common cause of skin infection in many locales in the U.S.

CA-MRSA strains are notable for their ability to spread in closed settings and cause recurrent infections among healthy persons. Management of recurrent CA-MRSA infection is challenging and optimal prevention strategies are undefined. Many experts recommend topical agents that decontaminate the body and/or anterior nares. However, there are no data that quantify the efficacy and safety of this approach.

We conducted a prospective non-comparative clinical trial to quantify the efficacy and safety of body decolonization regimens in the prevention of CA-MRSA infection from an Infectious Diseases private practice group in Northern California.

The study population comprised of persons suffering from recurrent CA-MRSA infection. For this clinical trial, all subjects will be given: nasal mupirocin (Bactroban Nasal, twice daily), topical 3% hexachlorophene body wash (Phisohex, daily), and an oral anti-MRSA antibiotic. The choice of oral antibiotic was based on investigators choice and antibiotic susceptibility of prior MRSA isolates in a given patient.

Patients were interviewed in person baseline and by phone at 2 weeks, 3 months, and 6 months using a standardized questionnaire. The baseline survey, based on a previously developed instrument used for an epidemiologic investigation of MRSA asked about MRSA risk factors and health-related quality of life. Follow up surveys asked about adverse drug effects, especially gastrointestinal and dermatologic side effects (2 week visit only) and incident skin and MRSA infections.

研究设计

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

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

  • recurrent MRSA infections and had greater than or equal to 2 MRSA infections in the 6 months prior to enrollment

排除标准

  • 未提供

研究组 & 干预措施

Nasal, body, and systemic decolonization

Experimental

干预措施: nasal mupirocin (Drug)

Nasal, body, and systemic decolonization

Experimental

干预措施: topical 3% hexachlorophene body wash (Drug)

Nasal, body, and systemic decolonization

Experimental

干预措施: oral anti-MRSA antibiotic (Drug)

结局指标

主要结局

A new MRSA or skin infection consistent with MRSA infection.

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other

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