Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone (AntibioCor)
Alcoholic Hepatitis, Alcoholic Liver Disease
About this trial
This is an interventional treatment trial for Alcoholic Hepatitis focused on measuring Alcoholic hepatitis, corticotherapy, antibiotherapy, survival, infection, hepato renal syndrome
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- CHU d'Amiens
- CHU
- CHU de Besançon
- Hôpital Jean Verdier (AH-HP)
- CHU de Caen
- Hôpital BEaujon (AP-HP)
- Centre hospitalier
- CHU Grenoble
- Hôpital Claude Huriez, CHU
- CHU Montpellier
- CHU Nantes
- CHU Nice
- Hôpital Saint Antoine (AP-HP)
- Hôpital La Pitié (AP-HP)
- CHU Poitiers
- CHU Pontchaillou
- CHU
- CHU
- Centre Hospitalier
- Hôpital Paul Brousse (AH-HP)
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
amoxicillin+ prednisolone
Placebo + prednisolone
Oral antibiotherapy during 30 days using amoxicillin+clavulanic acid at a daily dose of 3 gram (amoxicillin) and 375 mg (clavulanic acid) in three daily doses of 1g/125mg. Oral corticotherapy during 30 days with prednisolone at 40 mg/j in a single daily dose in the morning.
Oral placebo of amoxicillin- clavulanic acid in three daily doses during 30 days Oral corticotherapy during 30 days with prednisolone at 40 mg/j in a single daily dose in the morning.