Status:
COMPLETED
Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Alcoholic Hepatitis
Alcoholic Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for 28 days. However, about 25-35% of patients do not take benefit from this treatment and die within the 6 mont...
Detailed Description
This is a multicenter double-blind randomized controlled study on two parallel groups. Once inclusion and exclusion criteria verified and after having obtained patient written consent, participative ...
Eligibility Criteria
Inclusion
- Patients aged 18-75
- Recent onset of jaundice (\<3 months)
- Biopsy proven alcoholic hepatitis (transjugular liver biopsy)
- Maddrey's discriminant function ≥ 32, defining severe alcoholic hepatitis
- MELD score ≥21
- Alcohol consumption ≥ 40g/day (women) and ≥ 50g/day (men)
- Written informed consent
Exclusion
- Previous severe allergy or hypersensitivity to amoxicillin or clavulanic acid (anaphylactic shock, Quincke edema, severe urticaria)
- Hypersensitivity to any component of the medication
- History of liver injury to amoxicillin and/or clavulanic acid
- Phenylketonuria, because of the presence of aspartame in the powder for the oral suspension
- Type 1 hepatorenal syndrome before the initiation of treatment
- Severe extrahepatic disease
- Any malignant tumor \< 2 years
- Uncontrolled gastrointestinal bleeding
- Ongoing viral or parasitic infection
- Untreated bacterial infection.
Key Trial Info
Start Date :
June 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2019
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT02281929
Start Date
June 13 2015
End Date
November 19 2019
Last Update
December 22 2025
Active Locations (20)
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1
CHU d'Amiens
Amiens, France
2
CHU
Angers, France
3
CHU de Besançon
Besançon, France
4
Hôpital Jean Verdier (AH-HP)
Bondy, France, 93143