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Could a simple antibiotic boost survival in severe alcoholic hepatitis?

NCT ID NCT02281929

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding an antibiotic (amoxicillin-clavulanic acid) to the usual steroid treatment could improve survival in people with severe alcoholic hepatitis. About 300 adults at high risk of death within two months took part. The goal was to see if the antibiotic, given before any infection appeared, would help more patients be alive at two months compared to steroids alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

297 people

The number who actually took part.

Started

Jun 2015

Finished

Nov 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

alcoholic hepatitis alcoholic liver disease hepatorenal syndrome Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcoholic hepatitis Alcoholic liver disease

Contacts and locations

Locations

  • CHU

    Angers, France

  • CHU

    Rouen, France

  • CHU

    Toulouse, France

  • CHU Grenoble

    Grenoble, France

  • CHU Montpellier

    Montpellier, France

  • CHU Nantes

    Nantes, France

  • CHU Nice

    Nice, France

  • CHU Poitiers

    Poitiers, France

  • CHU Pontchaillou

    Rennes, France

  • CHU d'Amiens

    Amiens, France

  • CHU de Besançon

    Besançon, France

  • CHU de Caen

    Caen, France

  • Centre Hospitalier

    Valenciennes, 59300, France

  • Centre hospitalier

    Dunkirk, France

  • Hôpital BEaujon (AP-HP)

    Clichy, France

  • Hôpital Claude Huriez, CHU

    Lille, France

  • Hôpital Jean Verdier (AH-HP)

    Bondy, 93143, France

  • Hôpital La Pitié (AP-HP)

    Paris, France

  • Hôpital Paul Brousse (AH-HP)

    Villejuif, 94000, France

  • Hôpital Saint Antoine (AP-HP)

    Paris, 75012, France

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