Linezolid Alone or Combined With Carbapenem Against Methicillin-resistant Staphylococcus Aureus (MRSA) in Vitro and in Ventilator-associated Pneumonia
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- MRSA eradication
研究概览
简要总结
As previous studies showed that the synergy between linezolid and carbapenem in vitro and in vivo (animal studies), our study is aim to investigate the activity of linezolid, alone and in combination with carbapenem against methicillin-resistant Staphylococcus aureus (MRSA) in ventilator-associated pneumonia (VAP) patients.
详细描述
Linezolid is the only commercially available oxazolidinone, the first new class of antibiotic to be developed in the last three decades. Although it is predominantly bacteriostatic, linezolid has good in vitro and in vivo activity against MRSA . However, several studies did not show that linezolid was superior to any of glycopeptides in treatment of MRSA pneumonia. Moreover, combination therapy against MRSA is argued when several in vitro and in vivo studies showed synergy between linezolid and carbapenem or fosfomycin or rifampicin, while vancomycin and linezolid in combination should be avoided. our study is aim to investigate the activity of linezolid, alone and in combination with carbapenem against methicillin-resistant Staphylococcus aureus (MRSA) in ventilator-associated pneumonia (VAP) patients.
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
- •Pneumonia, Ventilator-associated
- •the presence of new or persistent radiographic features
- •fever higher than 38°C
- •leukocytosis (≥11.0 ×109/L) or neutropenia (≤3.5×109/L)
- •purulent endotracheal
- •increasing oxygen requirements
- •Endotracheal aspiration culture show methicillin-resistant S. aureus positive
排除标准
- •immunocompromised patients (postorgan transplantation or human immunodeficiency virus-infected or neutropenic [≤1×109/L absolute neutrophils], or patients receiving corticosteroids >20 mg/d for 6 months)
- •colonized chronically with methicillin-resistant S. aureus
- •pregnancy
- •endotracheal aspiration culture showed no MRSA
研究组 & 干预措施
Linezolid alone
the control group is designed for linezolid alone treated MRSA VAP (standard treatment).
干预措施: Imipenem/cilastatin (Drug)
结局指标
主要结局
MRSA eradication
时间窗: 7 th day
The investigators study the efficacy of Linezolid combined with Imipenem to treat the MRSA VAP, the investigators proposed the 7th day's MRSA eradication would be better than Linezolid alone.
次要结局
- mortality(28th day)
- MRSA eradication(14th day)