跳至主要内容
临床试验/EUCTR2006-004445-42-DE
EUCTR2006-004445-42-DE进行中(未招募)不适用

Pharmacokinetics of Cetriaxon in bone

Institut for Pharmacology and Toxicology0 个研究点目标入组 40 人开始时间: 2006年12月15日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • We will include patients (women and men) from 40 to 65 years which are, for clinical reasons, undergoing a hip replacement therapy in the participating centre. The patients must be able to understand and sign informed consent that the patient is willing to participate in the study.
  • Women must be postmenopausal.
  • We will use only patients with no relevant and accompanying diseases like:
  • prior traumatic surgery
  • past or present osteomyelitis
  • impaired function of the heart ( > NYHA II)
  • impaired function of the kidney (creatinine > 1,5 mg/ml)
  • impaired function of the liver (high GOT-value)
  • high body mass index (BMI > 35)
  • allergy against cephalosporine
  • allergy against ß-lactame-antibiotics
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patients who are unable to consent will not be included in the study.
  • Based on the literature, cephalosporine can be used in pregnancy. For safety reasons premenopausal women will be excluded from this trial.
  • We will exclude patients with relevant and accompanying diseases like:
  • prior traumatic surgery
  • past or present osteomyelitis
  • impaired function of the heart ( > NYHA II)
  • impaired function of the kidney (creatinine > 1,5 mg/ml)
  • impaired function of the liver (high GOT-value)
  • high body mass index (BMI > 35)
  • allergy against cephalosporine
  • allergy against ß-lactame-antibiotics

研究者

发起方
Institut for Pharmacology and Toxicology

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