NCT00603317

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 12, 2010

Status Verified

May 1, 2010

Enrollment Period

2 years

First QC Date

January 16, 2008

Last Update Submit

July 9, 2010

Conditions

Oral AnticoagulationDeep Venous ThrombosisAtrial FibrillationPulmonary Embolism

Keywords

WarfarinDrug interactionPharmacogeneticsAmoxicillinClavulanic acid

Outcome Measures

Primary Outcomes (1)

  • INR at day one and seven (delta Day7-Day1)

    7 days

Secondary Outcomes (1)

  • % 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

Study Arms (2)

1

EXPERIMENTAL

Order 1 : Firstly Amoxicillin-Acid clavulanic, and Secondly Placebo

Drug: Firstly : Amoxicillin-Clavulanic acid and secondly : Placebo

2

EXPERIMENTAL

Order 2 : Firstly Placebo, and Secondly Amoxicillin-Acid clavulanic

Drug: Firstly : Placebo and secondly : Amoxicillin-Clavulanic acid

Interventions

Firstly : Amoxicillin-Clavulanic acid and secondly : PlaceboDRUG

Amoxicillin : 2g twice daily Clavulanic acid : 125 mg twice daily

1
Firstly : Placebo and secondly : Amoxicillin-Clavulanic acidDRUG

Amoxicillin : 2g twice daily Clavulanic acid : 125mg twice daily seven consecutive days

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Lariboisière - Service de médecine interne

Paris, 75475, France

Location

MeSH Terms

Conditions

Venous ThrombosisAtrial FibrillationPulmonary Embolism

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesEmbolism

Study Officials

  • Stephane MD MOULY, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 12, 2010

Record last verified: 2010-05

Locations

FR(1)