Use of Aaerosol Combined With Intravenous Antibiotics for the Treatment of Multidrug Resistant GNB Pneumonia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CPIS score changes
研究概览
简要总结
To investigate use of aerosol combined with intravenous antibiotics for the treat of multi-drug resistance gram negative bacterias diagnosed ventilator-associated pneumonia in intensive care unit in a hospital.
详细描述
Ventilator-associated pneumonia (VAP) refers to the endotracheal tube or tracheostomy patients pneumonia after 48h of mechanical ventilation, mechanical ventilation is one of the most common and most serious complications, hospital acquired is An important cause of pneumonia. According to the onset time of VAP, VAP can be divided into early-onset VAP and late-onset VAP. The time limit is mechanical ventilation for 4 days, in which early-onset VAP (mechanical ventilation ≤ 4d) is mainly caused by pathogens sensitive to most antibacterial drugs (such as methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae, etc.); late-onset VAP ≥ 5D occur during mechanical ventilation, mainly caused by multi-drug resistant (multi-drug resistance, MDR) (such as P. aeruginosa, Acinetobacter baumannii, methicillin-resistant Staphylococcus aureus). Some early-onset VAPs can also be caused by MDR. Therefore, MDR has become the main pathogen of VAP, especially Gram-negative bacilli. Studies have shown that VDR caused by MDR has a mortality rate of 76% and an attributable mortality rate of 20-30%. Such bacteria are not sensitive to commonly used antibacterial drugs in the clinic, and sensitive antibiotics, such as aminoglycosides, have a large systemic side effect, thereby limiting clinical use. Therefore, in theory, nebulized inhaled sensitive antibiotics can achieve high drug concentrations in lung tissue, and lower blood concentrations can avoid or reduce systemic side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •・ After 48 hours of mechanical ventilation diagnosed VAP.
排除标准
- •who not meet the age limits,
- •used amikacin within 15 days,
- •allergic to amikacin,
- •APACHE II score > 35,
- •severe neutropenia unrelated to sepsis or meningitis,
- •unable to retain specimens
研究组 & 干预措施
aerosol combined group
aerosol combined intravenous antibiotics group,amikacin 15mg/kg, qd
干预措施: aerosol antibiotics (Drug)
结局指标
主要结局
CPIS score changes
时间窗: 14 days
use clinical pulmonary infection score scale to evaluate score change from baseline for every patient
renal function changes
时间窗: 14 days
record changes in renal function assessed by SCr, blood urea nitrogen,etc.
次要结局
- Drug resistance induction rate(14 days)
- ventilator free days in 14 days(14 days)
- 14-day mortality rate(14 days)
研究者
Sheng Wang MD PhD
Director, Principal investigator
Shanghai 10th People's Hospital
