Randomized Controlled Trial of Chlorhexidine Gluconate, Intranasal Mupirocin, Rifampin and Doxycycline Versus Chlorhexidine Gluconate and Intranasal Mupirocin Alone for the Eradication of Methicillin-resistant Staphylococcus Aureus Among an Ambulatory Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months
研究概览
简要总结
MRSA decolonization may reduce the risk of subsequent MRSA infection and further transmission. A recent randomized controlled trial demonstrated that systemic decolonization may be safe and effective among hospitalized patients when compared to no treatment. As a large number of the investigators patients require re-admission and further transmission may take place in the community, the investigators are comparing the standard decolonization protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory population.
Standard decolonization protocols, which use only topical agents, are limited in efficacy. The method of systemic decolonization to be studied here appears to have greater efficacy than the standard approach using only topical agents. However, concerns have been raised that the increased use of systemic antibiotics may lead to increased levels of drug resistance adverse effects, without sustained decolonization. This study seeks to provide further data to help answer these questions and provide guidance for further policy development and implementation.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient colonized with MRSA
排除标准
- •Currently on treatment with antibiotics
- •Pregnant or breastfeeding women
- •Active infection
- •Hepatic cirrhosis or abnormal INR due to liver disease
- •Decolonization in the previous two (2) months
- •MRSA bacteria resistant to one or more of the study medications
- •AST and ALT levels more than five times the upper limit of normal.
研究组 & 干预措施
Systemic decolonization
7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily)
干预措施: 2% mupirocin ointment (Other)
Systemic decolonization
7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily)
干预措施: Rifampin (Drug)
Systemic decolonization
7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily)
干预措施: Doxycycline (Drug)
Systemic decolonization
7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily)
干预措施: 4% chlorhexidine gluconate (Other)
Standard decolonization
7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day.
干预措施: 2% mupirocin ointment (Other)
Standard decolonization
7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day.
干预措施: 4% chlorhexidine gluconate (Other)
结局指标
主要结局
Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months
时间窗: 12 months
To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.
次要结局
- Changes in susceptibility patterns of MRSA isolates.(12 months)
研究者
Duncan Webster
Physician, Infectious Diseases and Medical Microbiology
Horizon Health Network
