Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Proportion of patients able to achieve therapeutic target
研究概览
简要总结
Effective antimicrobial use in the burn population is important since this population is at an increased risk for infections during their stay in hospital as a result of their burn injury. Tobramycin is an antibiotic that has activity against common burn wound associated pathogens, such as Pseudomonas Aeruginosa, and its use is becoming increasingly relevant due to the increased incidence of bacterial resistance to currently utilized antibiotics. Once daily dosing of tobramycin has been safely and effectively used in the majority of infected patients for many years with the proposed benefits of optimized antibacterial activity and reduced nephrotoxicity compared to traditional dosing. But, the once daily dosing regimen has yet to be validated in the burn population. The purpose of this study is to validate the plausibility of once daily tobramycin dosing in the burn population with intent to determine a safe, effective, and efficient dosing regimen for this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Adult burn patient (≥ 18 years old)
- •Total burn surface area less than 20%
- •At least 48 hours after the time of the initial burn injury event
- •Has a suspected or confirmed infection
- •Has been receiving antibiotic therapy for at least 24 hours
排除标准
- •Pediatric patients (< 18 years old);
- •Documented history of cochlear or vestibular injury
- •Creatinine clearance < 50 ml/min
- •Requiring any modality of dialysis
- •Has been receiving antibiotic therapy for longer than 72 hours
- •Known allergy or adverse reaction to aminoglycoside antibiotics
- •Known allergy or adverse reaction to sulfites
- •Diagnosis of Parkinson's disease or myasthenia gravis
研究组 & 干预措施
Once daily aminoglycoside
Once daily dosing of Tobramycin
干预措施: Tobramycin (Drug)
结局指标
主要结局
Proportion of patients able to achieve therapeutic target
时间窗: 24 hours
Clearance of tobramycin in the burn population
时间窗: 24 hours
Breakpoint in tobramycin volume of distribution based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds
时间窗: 24 hours
Volume of distribution of tobramycin in the burn population
时间窗: 24 hours
Breakpoint in tobramycin clearance based on time post-burn, body burn surface area, inhalation injury score, or percentage of open wounds
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Sandra Walker
Clinician Scientist
Sunnybrook Health Sciences Centre