Evaluation of the Safety and Efficacy of Nebulized Amikacin as Adjunctive Therapy in Hospital Acquired and Ventilator Associated Bacterial Pneumonia in Surgical Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 主要终点
- Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group
研究概览
简要总结
The investigator's goal in this study is to evaluate the efficacy and safety of nebulized amikacin versus intravenous amikacin in patients with hospital and ventilator acquired pneumonia in surgical patients admitted to the intensive care units infected with gram negative bacilli
详细描述
prospective, randomized, controlled study on post-cardiac surgery patients , included two groups, over one year period. The first group was administered intravenous (IV) amikacin 20 mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both groups were co-administered intravenous (IV) piperacillin/tazobactam empirically.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to ICU
- •Clinical suspicion of VAP or HAP defined by a new persistent radiological infiltrate and one of the following signs:
- •purulent tracheal aspirations, or
- •temperature of 38° or higher, or leucocyte count > 10000/ml or
- •Positive culture sensitive to amikacin
- •In case of empirical treatment, risk of multi resistant bacteria defined as follows:
- •Antimicrobial therapy in preceding 90 days and
- •Current hospitalization of 5 d or more
排除标准
- •History of Asthma
- •Multi organ failure or any psychiatric illness
- •allergy to amikacin or intolerance to nebulized amikacin
- •Myasthenia gravis.
- •Severely impaired renal function (creatinine clearance lower than 10 mL/min or renal replacement therapy)
- •Vestibulo-cochlear disease.
- •Pregnancy.
- •Brain death
研究组 & 干预措施
Nebulized Amikacin
patients in this arm will take amikacin nebulizer 400 mg twice daily in addition to standard beta lactam
干预措施: Nebulized Amikacin (Drug)
Amikacin Intravenous
patients in this arm will take intravenous (IV) amikacin 20 mg/kg once daily in addition to standard beta lactam
干预措施: Intravenous Amikacin (Drug)
结局指标
主要结局
Proportion of cured patients in the nebulized amikacin group versus the proportion of cured patients in the intravenous group
时间窗: through study completion, over one year
次要结局
未报告次要终点
研究者
NKhalek
Pharmacotherapy Specialist
National Heart Institute, Egypt