Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- INR at day one and seven (delta Day7-Day1)
研究概览
简要总结
Several case reports indicate that the use of the antibiotic combination amoxicillin and clavulanic acid (AM-CLAVAC) can interact with warfarin pharmacodynamics. However, fever per se might also be responsible of these warfarin overdose reports, as well as the use of high dose paracetamol.
The aim of the present study is to determine if AM-CLAVAC can increase the pharmacodynamics of warfarin among patients at steady state Double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose.
详细描述
Double blinded cross over controlled study vs placebo performed in 12 evaluable patients treated with warfarin with an INR target 2 to 3 and a stable INR and a stable dose
One period : seven consecutive days of amoxicillin(2g twice daily)- clavulanic acid (125 mg twice daily) association Wash out period of at least 4 weak with the return to a stable INR and warfarin dose One period : seven consecutive days of placebo twice daily
Main outcome INR delta Day7-Day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients treated with warfarin (target INR 2 to 3)
- •stable anticoagulation (3 consecutive INR in the target)
- •stable dose
- •no infection
- •normal CRP
- •age >18 years
- •normal transaminase levels
排除标准
- •drug allergy
- •penicillin allergy
- •Alzheimer
- •thyroid disease
- •gastro intestinal chronic disease
- •frequent nausea or vomiting
- •Cirrhosis
- •chronic renal failure (GFR<60 ml/min)
- •frequent intake of paracetamol or NSAID
- •addict to drugs or alcool
- •St John's wort treatment or grapefruit juice intake
- •concomitant drugs (amiodarone, cimetidine, SSRI, clofibrate, fenofibrate, diltiazem, fluconazole, itraconazole, isoniazide, voriconazole, métronidazole, miconazole , omeprazole, glucocorticoids, zileuton, ritonavir, rifampicin, carbamazepine, phenytoin, phenobarbital)
- •antibiotic use during the 3 last weeks
- •pregnancy
结局指标
主要结局
INR at day one and seven (delta Day7-Day1)
时间窗: 7 days
次要结局
- % of patients with an INR>3.5 during each study period mean INR during each study period effect of VKORC1 genetic polymorphism trough blood concentrations of S and R warfarin at day1 and day7 (delta) during each study period(7 days for each period)