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临床试验/CTRI/2024/06/068660
CTRI/2024/06/068660尚未招募Phase 3 4

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.

Department of Anaesthesiology and Critical Care1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年7月1日最近更新:

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

发起方
Department of Anaesthesiology and Critical Care
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sadik Mohammed

All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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