Antibiotikapenetration og vævsrespons ved infektion og rekonstruktiv kirurgi i hoved-hals regionen
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- T>MIC for all investigated antibiotics in the measured tissues and in plasma, calculated based on concentration–time profiles obtained from microdialysate samples and serial blood sampling. T>MIC will be calculated using predefined MIC target values for each IMP in the primary analysis: cefuroxime 4 mg/L, cloxacillin 2 mg/L, dicloxacillin 2 mg/L, and amoxicillin/clavulanic acid 2 mg/L, expressed as the amoxicillin component.
研究概览
简要总结
To determine antibiotic exposure in tissue and plasma during treatment with selected antibiotics
研究设计
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Either postoperative neck infection or planned reconstruction with an inferior turbinate flap (IFT flap)
- •Age above 18 years
排除标准
- •Known allergy or hypersensitivity to the administered antibiotics (cefuroxime, cloxacillin, dicloxacillin, or amoxicillin/clavulanic acid)
- •Pregnancy or planned pregnancy
- •eGFR <30 ml/min/1,73 m²
结局指标
主要结局
T>MIC for all investigated antibiotics in the measured tissues and in plasma, calculated based on concentration–time profiles obtained from microdialysate samples and serial blood sampling. T>MIC will be calculated using predefined MIC target values for each IMP in the primary analysis: cefuroxime 4 mg/L, cloxacillin 2 mg/L, dicloxacillin 2 mg/L, and amoxicillin/clavulanic acid 2 mg/L, expressed as the amoxicillin component.
T>MIC for all investigated antibiotics in the measured tissues and in plasma, calculated based on concentration–time profiles obtained from microdialysate samples and serial blood sampling. T>MIC will be calculated using predefined MIC target values for each IMP in the primary analysis: cefuroxime 4 mg/L, cloxacillin 2 mg/L, dicloxacillin 2 mg/L, and amoxicillin/clavulanic acid 2 mg/L, expressed as the amoxicillin component.
次要结局
- Pharmacokinetic parameters (Cmax, AUC, Tmax and T½) in tissue and plasma
- Concentrations of glucose, lactate, pyruvate and glycerol, as well as inflammatory proteins, in microdialysate samples
研究者
Tejs Ehlers Klug
Scientific
Region Midtjylland