跳至主要内容
临床试验/NCT01581047
NCT01581047已完成不适用

Pharmacokinetics of Small Spectrum Beta-lactam Antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) in Patients on Intensive Care Units

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2012年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Area under the serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid.

研究概览

简要总结

Adequate antibiotic therapy is very important in the treatment of infections. Spectrum and dosing of the antibiotics are two factors of the therapy: the spectrum of an antibiotic can't be changed, but the dosing scheme can be optimized. Recent studies proved that an optimized dosing scheme can improve the efficacy of the treatment. Broad-spectrum antibiotics have unpredictable pharmacokinetics in patients on intensive care units. This is due to the pathophysiologic processes in the patients on intensive care units: increased distribution volume, hypoproteinemia, organ failure... The investigators guess that similar processes influence the pharmacokinetics of small spectrum antibiotics (like amoxicillin and cefuroxime), but data lacks. Because the pharmacokinetics of broad spectrum antibiotics in seriously ill patients are better known, physicians are more confident prescribing these drugs. Studying the pharmacokinetic interactions of small spectrum antibiotics in seriously ill patients, can help to give the physician the confidence to prescribe these small-spectrum antibiotics.

In this study, the investigators will study the pharmacokinetics of amoxicillin/clavulanic acid and cefuroxime, in 60 patients on intensive care. 8 blood samples will be drawn via a central catheter on different moments after one administration of the antibiotic in the steady state phase. All the patients are prescribed the antibiotics for the treatment of their infections: they get the antibiotic therapy anyway. By measuring the concentrations on different moments after one administration, the investigators can reconstruct the pharmacokinetic function.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients on the intensive care unit, who are treated with amoxicillin/clavulanic acid or cefuroxime for an infection

排除标准

  • informed consent lacking
  • haematocrit < 21 %
  • arterial catheter lacking

结局指标

主要结局

Area under the serum concentration versus time curve (AUC) of Amoxicillin/Clavulanic acid.

时间窗: Before and at 15, 30, 45, 60, 120, 240 and 360 minutes after administration

The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC).

Area under the serum concentration versus time curve (AUC) of Cefuroxime.

时间窗: Before and at 15, 30, 45, 60, 120, 240 and 480 minutes after administration

The concentrations of the antibiotic in serum samples, drawn at various times after one administration, will be measured. With these data, we can calculate the time above the minimal inhibitory concentration (MIC).

次要结局

  • Rate of organ failure.(At date of admission (day 1) and dismissal (up to 3 months).)
  • Severity of disease classification.(At date of admission (day 1) and dismissal (up to 3 months).)
  • 24 hour urine creatinine clearance(At 24 hours)
  • Concentration serum albumin(At day 1.)
  • Concentration serum creatinin(At day 1.)
  • Change in fluid balance(From 0 to 24 hours.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Pharmacokinetics of Small Spectrum Beta-lactam... | 临床试验