Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 16, 2008
Trial Information
Current as of May 22, 2025
Completed
Keywords
ClinConnect Summary
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
Gender
ALL
Eligibility 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
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Trial Officials
Stephane MD MOULY, MD, PhD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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