Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients
研究概览
简要总结
Patients receiving acyclovir as standard of care will be enrolled into this study. The currently recommended dosing strategy at our institution for obese patients is to receive intravenous acyclovir dosed per an adjusted body weight [IBW + 0.4(TBW-IBW)]. They will have blood drawn once prior to the first dose of acyclovir and 10 times thereafter, over a total time period of 12 hours. These patients will already be hospitalized for other reasons, and will not be required to make additional trips to the hospital. A total of approximately 4-5 tablespoons of blood will be drawn for this study. Ten obese patients and 10 matched control (non-obese) patients will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 of age
- •Receiving intravenous acyclovir 5 mg/kg (TBW for normal weight patients and ABW40 for obese patients) as part of their routine care
- •Weight > 190% of ideal body weight (IBW) for "obese" patients or weight 80-120% of IBW for matched control patients.
排除标准
- •Receipt of acyclovir or a pro-drug of acyclovir (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours
- •Serum creatinine >1.5 mg/dL
- •Hypersensitivity to acyclovir
- •Patients requiring ventilator support or vasopressors in the prior 24 hours
- •Receipt of probenecid, mycophenolate, tenofovir, or zidovudine in the prior 7 days
- •Significant anatomical deformities that influence body habitus (i.e. amputation)
- •Prior inclusion in this study
研究组 & 干预措施
Obese Patients
Obese patients (patients whose weight is >190% of ideal body weight) will be receive a single dose of I.V. acyclovir sodium 5mg/kg dosed by adjusted body weight as part of their routine care.
Non-obese Patients
Normal weigh patients (patients whose weight is 80-120% of ideal body weight) will be receive a single dose of I.V. acyclovir sodium 5mg/kg dosed by total body weight as part of their routine care.
结局指标
主要结局
Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients
时间窗: 12 hours
次要结局
- Time that concentration is above IC50 for varicella and herpes viruses in obese and non-obese patients(12 hours)
- Systemic Clearance of acyclovir in obese and non-obese patients(12 hours)
- Half-life of acyclovir in obese and non-obese patients(12 hours)
- Maximum concentration (Cmax) of acyclovir in obese and non-obese patients(12 hours)
- Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients(12 hours)
- Volume of distribution (Vd) of acyclovir in obese and non-obese patients(12 hours)
研究者
Aaron Cumpston, PharmD, BCOP
Pharmacy Clinical Specialist
West Virginia University