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Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oral Anticoagulation; Deep Venous Thrombosis; Atrial Fibrillation; Pulmonary Embolism

Intervention: Firstly : Amoxicillin-Clavulanic acid and secondly : Placebo (Drug); Firstly : Placebo and secondly : Amoxicillin-Clavulanic acid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Stephane MD MOULY, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - HĂ´pitaux de Paris

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.

Clinical Details

Official title: Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: INR at day one and seven (delta Day7-Day1)

Secondary outcome: % 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

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

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- drug allergy

- penicillin allergy

- Alzheimer

- cancer

- 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

Locations and Contacts

Hopital Lariboisière - Service de médecine interne, Paris 75475, France
Additional Information

Starting date: March 2008
Last updated: July 9, 2010

Page last updated: August 23, 2015

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