A Pharmacokinetic-pharmacodynamic Dose Comparison Study of 8 mg/kg of Inhaled or Parenteral Gentamicin in 12 Mechanically Ventilated Critically Ill Patients Treated for Ventilator-associated Pneumonia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- "Peak Plasma Concentration (Cmax)"
研究概览
简要总结
Ventilator associated pneumonia (VAP) remains in the intensive care unit the infection associated with the highest morbidity and mortality.
Respiratory infection with resistant organism are increasing in prevalence. Because of lack of alternatives, amino glycoside, old antibiotics family, can be used for several infection.
Aerosolized Amikacin or Tobramycin are used in mechanically ventilated patients for respiratory infections. Gentamicin,which is effective against numerous multi drug resistant Gram-negative organism and Gram-positive like Staphylococcus aureus, could be a great option for nebulisation.
The investigators assume that nebulisation of gentamicin allows to obtain a higher lung concentration while assuring a systematic toxicity much lesser than a parenteral administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •to be in critical care unit
- •to be mechanically ventilated
- •to have a ventilator-associated pneumonia requiring a treatment by gentamicin
- •to be affiliated to a national insurance scheme
- •to have given an informed consent (patient or close person)
排除标准
- •to be obese (BMI > 40 kg/m²)
- •to have been treated by gentamicin for 7 days
- •to be allergic to aminoglycoside
- •to have a severe respiratory failure (PaO2 / FiO2 < 150)
- •to have a renal failure (Cl creat < 60 ml/min/1.73m²)
- •to be under reinforced protection measure
研究组 & 干预措施
Gentamicine injectable(day 1+2)and then gentamicine inhalation
干预措施: gentamicin (Drug)
结局指标
主要结局
"Peak Plasma Concentration (Cmax)"
时间窗: 3 days
次要结局
- PaO2/FiO2 ratio deterioration above 20%.(3 days)