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临床试验/NCT01923363
NCT01923363已完成不适用

Pharmacokinetics and Pharmacodynamics of High-Dose Piperacillin/Tazobactam in Obese Patients

Loma Linda University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2014年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Serum Maximum Concentrations for Piperacillin

研究概览

简要总结

Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for critically ill patients with an infection, however, limited information exists for dosing this drug in obese patients. In these limited reports, standard doses of piperacillin/tazobactam given to the small number of obese patients resulted in lower blood concentrations, which could lead to inadequate killing of bacteria. The purpose of this study is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to higher dosing regimens in obese patients. This study will also include information on the safety and tolerability of the higher dose regimens. The study investigators believe that the higher dosing regimen will produce adequate blood levels in obese patients and will not add any more risk of harm to obese patients receiving this higher dose.

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 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI greater than or equal to 30 kg/m2
  • Weight at least 105 kg
  • Age 18-89 years of age
  • Prescribed piperacillin/tazobactam at standard doses for suspected or confirmed infection(s)
  • English or Spanish speaking
  • Central line access

排除标准

  • Do not meet specified inclusion criteria
  • Hepatic impairment classified by Child-Pugh Class B or greater
  • Documented pre-existing seizure disorder
  • Documented pre-existing hematologic disorder
  • Pregnancy
  • Documented allergy or contraindication to beta-lactams or tazobactam

研究组 & 干预措施

Standard Dose to High Dose Piperacillin/Tazobactam

Experimental

Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.

干预措施: Piperacillin/Tazobactam Standard Dose to High Dose (Drug)

结局指标

主要结局

Serum Maximum Concentrations for Piperacillin

时间窗: 0, 1, 3, and 6 hours post-dose

Pharmacokinetic parameters for piperacillin of maximum serum concentration (Cmax) will be measured in both standard dosing and high dosing.

Serum Minimum Concentrations of Piperacillin

时间窗: 0, 1, 3, and 6 hours post-dose

Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses

次要结局

  • Half-life of Piperacillin(0, 1, 3, and 6 hours post-dose)
  • Volume of Distribution of Piperacillin(0, 1, 3, and 6 hours post-dose)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Forland

Clinical Pharmacy Specialist - Infectious Diseases

Loma Linda University

研究点 (1)

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