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临床试验/NCT01112995
NCT01112995已完成2 期

A Pilot Randomized Trial to Determine the Efficacy of a Probiotic, Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA)

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
49
试验地点
2
主要终点
The main outcomes will be the proportion of patients colonized with MRSA at 4 weeks, 8 weeks, 12 weeks and 24 weeks following start of treatment.

研究概览

简要总结

The purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, Lactobacillus rhamnosus versus oral placebo for reducing colonization by MRSA.

详细描述

Healthcare-associated infections are an important threat to patient safety. Currently, between 5 and 10 percent of patients admitted to acute care hospitals acquire one or more infections; healthcare-associated infections affect approximately 2 million patients each year in the United States, result in 90,000 deaths, and are associated with an added cost of $4.5 to $5.7 billion per year. Seventy percent of healthcare-associated infections are caused by antimicrobial resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), resulting in increased antimicrobial usage, morbidity and mortality, making prevention of multiresistant bacteria essential.

Eradication of colonization has been shown to greatly reduce infection; however, there are no reliable means of providing sustained eradication of colonization. No effective means of eradicating MRSA colonization exist.

Probiotics containing strains of lactobacilli represent a novel approach to the prevention and control of antimicrobial resistance and have been studied extensively for a variety of infections. Even though various studies have shown probiotics to be effective for prevention of vaginal infections, urinary tract infections, etc no studies have examined the potential of probiotics to eradicate colonization by resistant pathogens, such as MRSA.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • subjects will be male or female
  • 18 years of age or older
  • may or may not be hospitalized
  • able to take oral medications
  • have been found to be colonized with MRSA or at high risk of being colonized by MRSA and are not taking antibiotics

排除标准

  • people on antibiotics will not be eligible to participate

结局指标

主要结局

The main outcomes will be the proportion of patients colonized with MRSA at 4 weeks, 8 weeks, 12 weeks and 24 weeks following start of treatment.

时间窗: 24 weeks

次要结局

  • Incidence of clinical infections will be assessed in the one year following enrollment into the study(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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