NCT00603317

Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Oral Anticoagulation
• Deep Venous Thrombosis
• Atrial Fibrillation
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Firstly : Amoxicillin-Clavulanic acid and secondly : Placebo	Amoxicillin : 2g twice daily Clavulanic acid : 125 mg twice daily
DRUG	Firstly : Placebo and secondly : Amoxicillin-Clavulanic acid	Amoxicillin : 2g twice daily Clavulanic acid : 125mg twice daily seven consecutive days

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-01-29
• Last updated: 2010-07-12

Locations

1 site across 1 country: France