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临床试验/NCT00280514
NCT00280514已完成4 期

Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年1月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
2
主要终点
AUC

研究概览

简要总结

Penetration of cefpirome and moxifloaxacin into abscess fluid of humans will be tested. Patients with an abscess scheduled for drainage will receive study drugs (single or multiple dose), pus samples and plasma samples will be collected and analyzed by High pressure liquid chromatography (HPLC). Pharmacokinetics of the study drugs in pus and plasma will be determined using a pharmacokinetic model.

详细描述

Title: Plasma and abscess fluid pharmacokinetics of cefpirome and moxifloxacin single dose and multiple dose administration.

Background: Extensive research in the field of abscess treatment has established a claim for invasive drainage as the most efficient means of resolving suppurative lesions. In particular, computer tomography-guided percutaneous abscess drainage has repeatedly been reported to be advantageous compared to other invasive methods. However, application of the percutaneous interventional method is subject to some limitations. Coagulation abnormalities are considered a contraindication, and the absence of a safe anatomic access route, the presence of fistulas, severe inflammation of organs, or patients with advanced age have likewise been linked to low success rates of percutaneous abscess drainage. From these considerations, it becomes evident that percutaneous and surgical abscess drainage alone are not satisfactory in a number of patients suffering from abscess/infected cyst-related disease. In some patients antibiotic therapy is administered in bridging them to more stable conditions that drainage can be performed. Therefore, it is eminent for the overall outcome of patients to select an appropriate antibiotic. For this purpose, a model was recently developed to simulate the concentration time-curve of fosfomycin in abscess fluid after a single dose and after multiple doses.

Cefpirome and moxifloxacin are drugs which may be used in the empiric therapy of purulent infections. They may be used as monotherapy or they may be combined, e.g. with fosfomycin. Cefpirome is a 4th class cephalosporin with a broad spectrum (gram positive and gram negative pathogens), penetrating well into soft tissues. Moxifloxacin is a new fluoroquinolone with a considerable antimicrobial spectrum, also penetrating excellently into soft tissues. Based on the experiences with the methods and results obtained from our recent study on fosfomycin penetration into abscess fluid, the present pilot study will be set out to gain PK information on the penetration properties of cefpirome and moxifloxacin into abscess fluid and abdominal cysts.

Aim of the study: To determine pharmacokinetics of cefpirome and moxifloxacin in abscess (cyst) fluid and plasma after single and multiple doses.

Study design: Pharmacokinetic pilot study. Drug concentrations will be determined in abscess liquid upon drainage and in plasma over a period of eight hours.

研究设计

研究类型
Interventional
分配方式
Non Randomized

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Female or male, aged between 18 and 90 years.
  • Written informed consent.
  • Abscess formation or abdominal cyst scheduled to drainage.
  • Plasma creatinine <1.5 mg/dL

排除标准

  • Pregnancy or lactation.
  • Hemodialysis or hemofiltration
  • Allergy or hypersensitivity against study drugs
  • Massive edemata or hypernatremia
  • Reduced liver function (Child-Pugh A, B, C)
  • Relevant prolongation of QT-interval
  • CNS-diseases which predispose for cramps

结局指标

主要结局

AUC

AUC0-12/24h

Cmax

Tmax

t1/2ß

Cav(ss)

次要结局

  • ratios of AUC and Cav(ss) to MIC
  • T>MIC

研究者

申办方类型
Other

研究点 (2)

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