NCT03149640已完成3 期
Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 850
- 试验地点
- 16
- 主要终点
- Incidence of a first VAP episode from randomization to day 28
研究概览
简要总结
The objective of the study is to prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP.
Parallel two group double blind randomized controlled clinical trial. Individual randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on centre in order to account for variations in VAP prevention bundle implementation and use of systemic antibiotics the day of randomization. Patients will be treated three consecutive days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive care unit for the occurrence of VAP according to international guidelines until day 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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 the day of inclusion
- •Mechanical ventilation through an endotracheal tube for more than three consecutive days (72h)
- •Written informed consent of the patient or a proxy
- •Patients covered by or having the rights to French social security
- •Negative pregnancy test, at the time of inclusion, in women of childbearing potential
排除标准
- •Suspicion or confirmed VAP the day of inclusion
- •Clinical indication for systemic aminoglycoside therapy the day of inclusion : as deemed necessary by the clinician in charge
- •Stage 2 or 3 KDIGO* classification acute kidney injury the day of inclusion excepted in patients undergoing renal replacement therapy
- •Chronic kidney failure : baseline glomerular filtration lower than 30 mL/min
- •Patient scheduled for extubation within the next 24h
- •Patient ventilated through an endotracheal tube for more than four consecutive days before inclusion (96h)
- •Patient ventilated through a tracheostomy
- •Patients allergic to aminoglycosides
- •Myasthenia gravis
- •Known pregnant women at the time of inclusion and lactating patients
- •Known guardianship or trusteeship at the time of inclusion
- •Patients previously included in this study
研究组 & 干预措施
Inhaled amikacin
Experimental
Inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.
干预措施: Inhaled amikacin (Drug)
Placebo
Placebo Comparator
Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.
干预措施: Inhaled placebo (Drug)
结局指标
主要结局
Incidence of a first VAP episode from randomization to day 28
时间窗: Patients will be followed from randomization to day 28
次要结局
- Clinical pulmonary infection score evolution(Patients will be followed from randomization to day 28)
- Incidence of VAP due to Gram negative amikacin sensitive bacteria(Patients will be followed from randomization to day 28)
- Number of days with at least one administration of a systemic antibiotic(Patients will be followed from randomization to day 28)
- Incidence of acute kidney injury(Patients will be followed from randomization to day 28)
- Ventilator associated events incidence(Patients will be followed from randomization to day 28)
- Days from randomization to the first successful spontaneous breathing trial(Days from randomization to day 90 max)
- Relative bacterial species composition of respiratory and digestive microbiota(Patients will be followed from randomization to day 28)
- Days spent on mechanical ventilation from randomization to day 90(Patients will be followed from randomization to day 90)
- Incidence of a first VAP episode in the subgroups of patients with tracheobronchial colonization or tracheobronchitis(At randomization)
- Number of systemic antibiotics administered per day(Patients will be followed from randomization to day 28)
- Incidence of antibiotic resistant bacteria isolated on clinical and hygiene samples(Patients will be followed from randomization to day 28)
- Day 90 mortality(Day 90)
- Incidence of bacteria producing extended spectrum beta-lactamase or high level derepressed celphalosporinase, of vancomycin resistant Enterococcus Sp. on rectal samples(Day 28)
- Maximum serum Concentration(Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24)
- Days spent in the intensive care unit and in the hospital(Patients will be followed from randomization to discharge (day 90 max))
- To evaluate the effects on respiratory mechanics of nebulization of amikacin by evaluating the benefit balance / risk(Measurements at 8 hours, 12 hours and 24 hours after the end of nebulization)
- Maximum sputum Concentration(Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24)
- Area Under the Curve(Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24)
研究者
研究点 (16)
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