Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone

PHASE3CompletedINTERVENTIONAL
Enrollment

297

Participants

Timeline

Start Date

June 13, 2015

Primary Completion Date

November 19, 2019

Study Completion Date

November 19, 2019

Conditions
Alcoholic HepatitisAlcoholic Liver Disease
Interventions
DRUG

Amoxicillin

Amoxicillin+clavulanic acid at a daily dose of 3 gram / 375 mg in three daily doses of 1g/125mg, during 30 days

DRUG

Placebo

Placebo in three daily doses during 30 days

DRUG

Prednisolone

Prednisolone at 40 mg/j in a single daily dose in the morning, during 30 days

Trial Locations (20)

59300

Centre Hospitalier, Valenciennes

75012

Hôpital Saint Antoine (AP-HP), Paris

93143

Hôpital Jean Verdier (AH-HP), Bondy

94000

Hôpital Paul Brousse (AH-HP), Villejuif

Unknown

CHU d'Amiens, Amiens

CHU, Angers

CHU de Besançon, Besançon

CHU de Caen, Caen

Hôpital BEaujon (AP-HP), Clichy

Centre hospitalier, Dunkirk

CHU Grenoble, Grenoble

Hôpital Claude Huriez, CHU, Lille

CHU Montpellier, Montpellier

CHU Nantes, Nantes

CHU Nice, Nice

Hôpital La Pitié (AP-HP), Paris

CHU Poitiers, Poitiers

CHU Pontchaillou, Rennes

CHU, Rouen

CHU, Toulouse

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

lead

University Hospital, Lille

OTHER

NCT02281929 - Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone | Biotech Hunter | Biotech Hunter