Cultures Before and After Decolonization in Community Dwelling Adults With Current S. Aureus Colonization
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization
研究概览
简要总结
The investigators propose to study the microbiome of the nose, throat and three skin sites in a population without current exposure to the healthcare environment: 80 community dwelling adults. We will characterize the microbial communities in these body sites (nose, throat, perirectal and three skin sites) over time using culture-independent techniques. The investigators will then "decolonize" the subjects. Subjects will receive intranasal mupirocin and topical chlorhexidine. The investigators will then compare the microbial communities at baseline and after decolonization within individuals. Our overall hypothesis is that the microbial composition of these sites and the response to decolonization is influenced by the healthcare environment and that decolonization leads to re-colonization with an increasing proportion of Gram-negative bacilli.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Veteran living in the greater Baltimore, MD area
- •Adults >= 18 years of age
- •Living independently
- •Willing and able to provide anterior nares, skin, throat, and perirectal specimens over an 18 week time period.
- •Willing and able to administer intranasal mupirocin and topical chlorhexidine over a five day period
- •Capable of understanding and complying with the entire study protocol.
- •Provided signed and dated informed consent
排除标准
- •Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the past 6 months
- •History of HIV infection with most recent CD4 of <200
- •Immunosuppression medications within the past 3 months
- •Use of systemic antibacterial or antifungal agents in the past 3 months
- •Use of nasal steroids currently or in the past 3 months
- •Use of nasal antimicrobial ointment in the past 3 months
- •Any current indwelling percutaneous medical device or urinary catheter
- •Acute care hospitalization in the past 3 months
- •Planned surgery or hospitalization during the study period
- •History of an allergic reaction to chlorhexidine or mupirocin
- •Oral temperature of >100 F at enrollment visit
- •BMI <18 or >35 at enrollment visit
研究组 & 干预措施
Intranasal Mupirocin and Topical Chlorhexidine
Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
干预措施: Mupirocin calcium ointment, 2% (Drug)
Intranasal Mupirocin and Topical Chlorhexidine
Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
干预措施: Topical Chlorhexidine, 4% (Drug)
结局指标
主要结局
Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization
时间窗: 8 weeks
Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.
Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization
时间窗: 8 weeks
Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration.
Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization
时间窗: 12 months
Quantitative PCR using 16S rRNA is used to quantify the total bacterial load of Gram negative bacteria on the subclavian skin before and after decolonization.
Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization
时间窗: 12 months
Quantitative PCR using 16S rRNA is used to quantify the total bacterial load of Gram negative bacteria on the femoral skin before and after decolonization.
次要结局
未报告次要终点