drugset / Trial / NCT00603317

Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid

NCT00603317

Phase 4 Completed 13 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2008-03
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 2 g
Subject clavulanic acid Small molecule 125 mg