Treatment of Patients Colonized With Methicillin-Resistant Staphylococcus Aureus Prior to Bone and Joint Surgery (TOPS-MRSA)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization
研究概览
简要总结
The investigators anticipate that utilization of retapamulin preoperatively will eliminate MRSA colonization among patients who are colonized in their nares.
详细描述
Enhanced characterization of MRSA strains carried by patients and their eradication prior to surgery will significantly reduce healthcare costs to the VA by reducing the number of MRSA positive patients who need to be isolated and or closely monitored, and allow healthcare providers to better predict the patient's requirements. In addition, the application of molecular methods will facilitate faster tracking of MRSA postoperative infections.
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 (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are admitted for an orthopedic surgical procedure
- •All patients will be screened and admitted to the study prior to surgery regardless of eventual culture results for MRSA
排除标准
- •Pregnancy
- •Serious systemic illness due to renal, cardiac or hepatic disease
- •Inability to complete follow-up assessments
- •Allergy or intolerance to retapamulin
- •BMI > 30
- •Uncontrolled diabetes, severe anemia, thrombocytopenia or an underlying hematopoietic disorder or malignancy
- •Patients with serious life-threatening illnesses and those with terminal illness not expected to survive for two years or more will not be enrolled
- •Antibiotics administered during the course of the study will be recorded (name, dose and dates)
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Altabax
干预措施: Altabax (retapamulin) (Drug)
结局指标
主要结局
Evaluate efficacy of Retapamulin 1% ointment in eliminating patients MRSA colonization
时间窗: 30 days
次要结局
- Identify a predominant clone among the MRSA isolates in this study(2 years)