A Randomized Open Label Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).
研究概览
简要总结
Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen. It is currently the fourth most common cause of pneumonia and fifth most common cause of bacteremia in intensive care patients (1-3).
The aim of the present randomized controlled trial is to assess the efficacy of non-absorbable oral antibiotics in the eradication of the KPC carrier state.
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
- •Inclusion Criteria
- •Patient identified as a KPC carrier.
- •Patient capable to understand and sign informed consent
- •Patient capable to receive oral medication
排除标准
- •Exclusion Criteria:
- •Patient unable to sign informed consent
- •Pregnant/lactating female
- •Patient not expected to survive > 2 weeks.
- •Patient unable or not allowed to receive oral medications
- •A known allergy to study drugs.
研究组 & 干预措施
Group 3: will receive both medications
干预措施: both medications (Drug)
Group 1: will receive PO Garamycin 80mg x 4/d
will receive PO Garamycin 80mg x 4/d
干预措施: PO Garamycin 80mg x 4/d (Drug)
Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d
干预措施: Colistin (Polymyxin E) 100mg x 4/d (Drug)
Group 4: will not receive PO treatment
干预措施: will not receive PO treatment (Drug)
结局指标
主要结局
The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).
时间窗: twice a week
- Is this outcome measure assessing a safety issue? Select: no
次要结局
未报告次要终点
研究者
rambam68
prof
Rambam Health Care Campus