Effect of prophylactic nebulization of Colistin versus Amikacin on the incidence of ventilator-associated pneumonia in an intensive care unit setting with prevalent multidrug-resistant bacteria: A prospective double-blind randomized placebo-controlled trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- To compare the incidence of VAP at Day 14
研究概览
简要总结
To study the effect of prophylactic nebulization of antibiotics on VAP reduction in an ICU with multidrug resistant bacteria, patients >18 years and requiring mechanical ventilation duration for >72 hours (total 156 patients), will receive either nebulization with colistin (colistimethate sodium, 1.5M IU, diluted in water for injection) or with amikacin (amikacin at a dose of 20 mg per kilogram of ideal body weight) or with an equivalent volume of 0.9% normal saline once a day for 3 days prepared by an investigator in a 5 mL syringe labeled as ‘study drug’. Disposable vibrating mesh nebulizer will be placed in the inspiratory limb of the ventilatory circuit. Complications if any will be noted. Data will be compiled and appropriate statistical test will be applied to analyse the result. The study results may be used to provide recommendation regarding the use of prophylactic antibiotics for VAP prevention particularly in the setting with prevalent multi-drug resistant bacteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients requiring mechanical ventilation for more than 72 hours.
排除标准
- •Grossly purulent sputum or pneumonia on admission; new and persistent infiltrates on chest radiography within 48 hours from admission.
- •Severe chronic obstructive pulmonary disease (COPD) or preexisting lung disease requiring long-term inhalation drug therapy.
- •Long-term therapy with corticosteroids or immunosuppressive drugs, human immunodeficiency virus infection, cancer.
- •Colonization or infection with a strain resistant to colistin and amikacin on admission.
- •Acute kidney injury on the day of inclusion.
- •Patients undergoing renal replacement therapy or for whom a decision had been made to initiate renal replacement therapy can be included whatever the KDIGO stage.
- •Chronic kidney failure.
- •Pregnancy and breastfeeding women.
- •Allergy to colistin or amikacin.
- •Myasthenia gravis.
结局指标
主要结局
To compare the incidence of VAP at Day 14
时间窗: At Day 14
次要结局
- To compare the incidence of VAP at day 28.(Comparison of VAP incidence due to organisms with in vitro susceptibility to study drug.)
研究者
Dr Sadik Mohammed
All India Institute of Medical Sciences, Jodhpur
