Extended Interval Dosing of Gentamicin in Neonates to Achieve Target Drug Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Trough gentamicin levels
研究概览
简要总结
A previous pharmacy residency project was done 20 years ago looking at the best dosing for the antibiotic gentamicin for babies up to 7 days old. This study showed that giving the dose less often leads to better drug concentrations than giving the dose more often. Our gentamicin dosing at the Children's Hospital at London Health Sciences Centre is based on the better dosing from the study. This dosing is gentamicin 3 mg/kg every 24 hours for babies less than 35 weeks gestational age and 3.5 mg/kg every 24 hours for babies at least 35 weeks gestational age. These results were never published. Different dosing is used at different hospitals. It is important that we check that our gentamicin dosing is still reaching safe and effective drug concentrations in the current study. The study will look at the gentamicin drug concentrations of babies up to 7 days old, including premature and term babies. We will also confirm if the babies have kidney or hearing damage from gentamicin. We will compare the gentamicin drug concentrations from this study to the past data to see if the dosing is still the best. The results can help form a guideline for the Children's Hospital and surrounding hospitals.
详细描述
Current gentamicin dosing at the Children's Hospital is based on the previous projects completed at LHSC. Different gentamicin dosing recommendations exist depending on the reference used. This study would help validate if the current extended interval dosing in neonates is still achieving target gentamicin concentration levels. We will compare the results of the current study to our historic data. The results will help determine if infants are receiving effective and safe treatment with gentamicin. Depending on the results of the study, further evaluation on changes to gentamicin dosing may be needed or an official guideline may be published if gentamicin levels are being adequately achieved with the current dosing. This official guideline will help prescribers at the Children's Hospital and hospitals in the surrounding region that will adopt our dosing when treating infants. There will be an overall benefit to prescribers and patients ensuring safe and effective of gentamicin dosing is followed. If the infant meets the study inclusion criteria, a letter of information will be provided to the parent(s)/guardian(s) if agreeable using REDCap. Consent must be obtained prior to enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates up to 7 days of age,
- •Neonate must be on gentamicin, and
- •Gentamicin trough and peak levels must be available for the third dose of gentamicin.
排除标准
- •Incorrect dose for weight (+/- 10% allowed to account for dose rounding)
- •Multiple levels from the same patient; only the first set of levels will be collected
- •Baseline renal dysfunction (e.g. congenital kidney disease)
- •On other nephrotoxic or ototoxic drugs concurrently with the first 3 days of gentamicin
研究组 & 干预措施
Neonates at least 35 weeks gestational age
干预措施: Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours (Other)
Neonates less than 35 weeks gestational age
干预措施: Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours (Other)
结局指标
主要结局
Trough gentamicin levels
时间窗: Day 3 of treatment: prior to the third gentamicin dose
The primary objective is to measure and monitor the number of trough gentamicin levels within target range \< 2 mg/L with the current extended interval dosing regimen compared to traditional dosing in neonates ≤ 7 days of age.
次要结局
- Peak gentamicin levels(Day 3 of treatment: following the third gentamicin dose)
- Incidence of suspected nephrotoxicity(Seven days after discontinuation of gentamicin)
- Incidence of suspected ototoxicity(Up to 7 days following gentamicin discontinuation while infant is still admitted in hospital)
研究者
Venita Harris
Pharmacy Residency Specialist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's