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
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