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Completed

NCT Number: NCT02281929

Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone

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 months following the diagnosis. Numerous trials have evaluated the impact of several strategies in association with corticosteroids. None of them has shown an improvement in survival (primary endpoint) as compared to corticosteroids alone.

The project is based on an approach never tested in a randomized controlled trial in severe alcoholic hepatitis, targeting the group of patients at high risk of death (25-35% at 2 months). This approach is based on animal and human studies.Antibiotics are effective in animal models and in other circumstances characterized by liver failure such as gastrointestinal bleeding related to portal hypertension. The interest of studying this population is emphasized by the frequency of infections in these critically ill patients. Antibiotics will be administered before the development of any infection, as it is likely that these patients present with mesenteric bacterial adenitis without systemic signs of infection. Primary endpoint will be 2-month survival as most deaths occur within 60 days and treatment is given for 30 days.

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Key information

Conditions

Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Alcoholic Liver Disease Chemically-Induced Disorders Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepatitis Hepatitis, Alcoholic Hepatorenal Syndrome Infections Kidney Diseases Liver Diseases Liver Diseases, Alcoholic Male Urogenital Diseases Substance-Related Disorders Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU d'Amiens, Amiens, France

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About this study

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 centers will process to inclusion in the trial.

Corticosteroids as well as antibiotics or their placebo will be started orally. Patients will be managed in the hospital unit until day 7, which corresponds to the evaluation of response to treatment using the Lille model. After this 7-day period, patients will be followed-up at day 14, day 21, day 30, day 60 (primary endpoint).

During each visit, biological and clinical features including efficacy and tolerance will be assessed as well as presence of infection and hepatorenal syndrome (secondary endpoints).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amoxicillin

Drug

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

Other names: Amoxicillin + clavulanic acid

Placebo

Drug

Placebo in three daily doses during 30 days

Other names: Placebo of amoxicillin

Prednisolone

Drug

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

Other names: corticotherapy

Primary outcomes

  1. Patient alive

    Time frame: at day 60

    The percentage of patients alive at 2 months in the experimental arm compared to the percentage of patients alive in the control arm

Secondary outcomes

  1. Infection

    Time frame: at day 7, day14, day 21, day 30, day 60; at 3 months, at 6 months

    incidence of infection over the 2-month period in the antibiotic+corticosteroid arm as compared to the control arm

  2. Hepatorenal syndrome

    Time frame: at day 7, day14, day 21, day 30,at 3 months, at 6 months

    incidence of hepatorenal syndrome over the 2-month period in the antibiotic+corticosteroid arm as compared to the control arm

  3. MELD score <17

    Time frame: at day 7, day14, day 21, day 30,

    percentage of patients with a low risk of mortality during the first two months (assessed by a MELD score <17) in the two arms of treatment. The MELD score will be calculated using the following formula:(9.57 × log creatinine in milligrams per deciliter) + (3.78 × log bilirubin in milligrams per deciliter) + (11.20 × log international normalized ratio) + 6.43.

  4. Lille Model

    Time frame: at day 7, after the first administration of treatment

    percentage of patients disclosing a response to treatment assessed by the Lille model (<0.45) in the two arms of treatment.

  5. Patient alive

    Time frame: at 3 months, at 6 months

    The percentage of patients alive at 2 months in the experimental arm compared to the percentage of patients alive in the control arm

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Evaluation of the Efficacy of an Antibiotic Combined With Standard Treatment in Severe Alcoholic Hepatitis

Acronym: AntibioCor

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 4, 2014
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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