EUCTR2018-000109-22-CZ进行中（未招募）1 期
Monitoring of efficacy of antibiotic prophylaxis in thoracic surgery - MONATPRO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •1. Male and female = 18 years old
- •2. Selective thoracic surgery with expected lenght more than 1 hour
- •3. Ability to understand and sign informed consent
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Allergy to cefazolin
- •2. Ongoing infection treated with systemic antibiotics
- •3. Renal failure with creatinine clearance lower that 35 ml/min/1,73 m2 based on preoperative laboratory results.
- •4. Pregnant and breastfeeding woman cannot be enrolled to this study. For women of childbearing potential, the pregnancy will be excluded by pregnancy test prior surgery.
- •5. Patients with contraindications listed in the currently valid SmPC of the investigational products.
研究者
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