The Effect of Colistin Inhalation on the Clinical Outcome of Patients With Ventilator Associated Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Assessment of Ventilatory status
研究概览
简要总结
The study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age 18 years
- •Patients presenting with signs of infection 48 hours of intubation
排除标准
- •Patients with documented bronchiectasis
- •Cystic fibrosis Known allergy to polymyxin. Patients presenting with chest infection or signs of infection before intubation.
- •Patients with creatinine clearance less than 30ml/min.
研究组 & 干预措施
Medication arm
Colistin to be given as 2 millions three times daily in the inhalation form from 5 to 7 days in addition to another antipseudomonal antibiotic according to infectious disease society of antimicrobials (IDSA) guidelines from day 1 of incidence of ventilator associated pneumonia
干预措施: Colistin (Drug)
Control arm
Patients receive antipseudomonal antibiotics IV as carbapenem and quinolone or aminoglycoside according to IDSA guidelines from day 1 of incidence of Ventilator associated pneumonia carbapenem as 1g three times daily + tavanic 750mg once daily or ciprofloxacin 500mg twice daily or aminoglycoside according to renal function
干预措施: Carbapenem + Aminoglycoside/ Quinolone (Drug)
结局指标
主要结局
Assessment of Ventilatory status
时间窗: 7 to 10 days
Pf ratio measurement
次要结局
- Days of mechanical ventilation(35 Days)
- Time till the occurence of sepsis(35 Days)
- Mortality as an outcome of long stand untreatable ventilator associated pneumonia(35 days)
- Length of stay in the icu(35 days)
研究者
Nourhan Hassan Osama Thuraya Mohamed
Clinical pharmacist
Ain Shams University