A Randomized,Double-Blind,Placebo-Controled Trial of Selective Digestive Decontamination Using Oral Gentamicin and Oral Polymyxin E for Eradication of Carbapenem-Resistant Klebsiella Pneumoniae Carriage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Eradication of CRKP carriage measured by negative rectal swabs
研究概览
简要总结
There is an urgent need to control our current national outbreak of carbapenem-resistant Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and polymyxin E administration. This will reduce infections and hopefully mortality caused by CRKP.
研究设计
- 研究类型
- Interventional
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
- •Hospitalized men and women with a positive rectal swab for CRKP
- •Age 18 years or older
排除标准
- •Age less than 18 years
- •Pregnant women, lactating women
- •A known allergy to the study drugs
研究组 & 干预措施
1
Oral solution and buccal gel of gentamicin and polymyxin E
干预措施: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo. (Drug)
2
Oral solution of 0.45% saline and oral solution of H2O & saccharine. Oral gel composed of mineral oil, gelatine powder, pectin, sodium carboxymethylcellulose, polyethylene
干预措施: Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo. (Drug)
结局指标
主要结局
Eradication of CRKP carriage measured by negative rectal swabs
时间窗: Two days after treatment ends
次要结局
- No new in-hospital acquisition of CRKP(Six weeks)