NCT00668044已完成3 期
A Population Pharmacokinetics Study of Plasma Levels of Ciprofloxacin Following a Regimen of Repeated Dose I.V. Administration (400 mg TID) on Burn Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 18
- 主要终点
- Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model
研究概览
简要总结
This was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead is over or under dosed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe burnt patients defined as burning of 20 to 60% of total body surface according to rule of nine, II deep degree and III degree according to Full-Thickness Burn model,
- •Hospitalization for burning injury since at least 72h during hyper metabolic phase
- •Active infections microbiological confirmed
- •Signed informed consent
排除标准
- •Pregnant or lactating female patients
- •Previous history of tendinopathy
- •Knowing syndrome of QTc prolongation
- •Impairment renal function
- •Hepatic insufficiency
- •Convulsion
- •Limited life expectancy
研究组 & 干预措施
Arm 1
Experimental
干预措施: Ciprofloxacin (BAYO9867) (Drug)
Arm 2
Experimental
干预措施: Ciprofloxacin (BAYO9867) (Drug)
结局指标
主要结局
Achievement of a population mean plasma level/time profile for the 400mg i.v. ciprofloxacin aimed to validate a pk model
时间窗: >72 h post injury, 48h and 120 h after treatment
次要结局
- Evaluation of AreaUnderCurve/Minimal Inhibiting Concentration Ratio(>72 h post injury, 48h and 120 h after treatment)
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