2023-510075-63-00招募中3 期
A multicentre, double-blind, randomized controlled trial of inhaled amikacin versus placebo in critically ill patients with ventilator-associated tracheobronchitis (AMIVAT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- Incidence of transition from VAT to VAP at Day 28
研究概览
简要总结
To assess whether a 5-day course of inhaled amikacin, compared to placebo, reduces the risk of progression to ventilator-associated pneumonia (VAP) at Day 28 in Intensive care unit (ICU) patients with ventilator-associated tracheobronchitis (VAT)
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up visits (Day 7, Day 28, and Day 90)
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •First episode of VAT during the ICU stay
- •Coverage by the French health insurance system (Social Security)
- •Written informed consent obtained from the patient, or, if the patient is not able to give written consent, from his or her legally designated representative (trusted person designated by the patient, or failing that a family member) and, failing that due to the urgency of the situation, inclusion will be performed by the investigator within the therapeutic window
- •For woman of childbearing potential: a negative pregnancy test result at the time of inclusion and contraception using an acceptable birth control method (CTFG recommendation)
排除标准
- •Previous VAP due to the pathogens responsible for VAT during the same ICU stay
- •Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship)
- •Moribund patient
- •End-of-life decision
- •Previous inclusion in the present study
- •On-going VAP (currently being treated)
- •VAT due to pathogens with intrinsic naturally amikacin resistance
- •On-going therapy with amikacin IV
- •AKI stage 2 or 3 of the KDIGO classification and/or advanced chronic kidney failure (glomerular filtration rate <30 mL/min), except in patients under renal replacement therapy (RRT)
- •Grade B or C cirrhosis (Child-Pugh classification)
- •Scheduled extubation within 24h
- •Known allergy to aminoglycosides
- •Myasthenia gravis
结局指标
主要结局
Incidence of transition from VAT to VAP at Day 28
Incidence of transition from VAT to VAP at Day 28
次要结局
- Incidence of transition from VAT to VAP at Day 7
- Overall incidence of a first VAP episode (all pathogens) at Day 28
- Overall incidence of a first VAP episode due to MDRB at Day 28
- Time to resolution of clinical signs of VAT
- Persistence of the pathogens responsible for VAT on ETA at Day 7
- Total duration of MV
- Number of ventilator-free days at Day 28
- Number of defined daily doses of systemic antibiotics (i.e., intravenous and/or enteral administration) at Day 28
- Incidence of ICU-acquired intestinal colonization with MDRB at Day 28
- Overall incidence of ICU-acquired infection due to MDRB at Day 28
- ICU and hospital LOS
- All-cause Day-28 and Day-90 mortality rates
- HRQoL in survivors at Day 90
- Occurrence of respiratory adverse events related to amikacin nebulization (safety analysis)
- Incidence of AKI at Day 28 (safety analysis)
- Pharmacokinetics of inhaled amikacin (pre-planned subsample).
研究者
BARBIER François
Scientific
Centre Hospitalier Regional Universitaire De Tours
研究点 (14)
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