AzTrials
AzTrials

Alcoholic HepatitisPhase 3AntibioCorNCT02281929

Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone

A Phase 3 study testing Amoxicillin and Prednisolone in people with Alcoholic Hepatitis and Alcoholic Liver Disease, run by University Hospital, Lille at 20 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 months following the diagnosis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Alcoholic Hepatitis, Alcoholic Liver Disease
What is being tested?
Amoxicillin and Prednisolone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
297 participants
Where
20 sitesFrance
Study dates
13 Jun 2015to 19 Nov 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Any malignant tumor < 2 years
  • Uncontrolled gastrointestinal bleeding
  • Ongoing viral or parasitic infection
  • Untreated bacterial infection.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • CHU d'Amiens

    Amiens

  • CHU

    Angers

  • CHU de Besançon

    Besançon

  • Hôpital Jean Verdier (AH-HP)

    Bondy, 93143

  • 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 Saint Antoine (AP-HP)

    Paris, 75012

  • Hôpital La Pitié (AP-HP)

    Paris

  • CHU Poitiers

    Poitiers

  • CHU Pontchaillou

    Rennes

  • CHU

    Rouen

  • CHU

    Toulouse

  • Centre Hospitalier

    Valenciennes, 59300

  • Hôpital Paul Brousse (AH-HP)

    Villejuif, 94000

Other trials in France

About this study

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

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.

Read the 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 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).

Being tested
Amoxicillin, Placebo, Prednisolone
Keywords
Alcoholic hepatitis, corticotherapy, antibiotherapy, survival, infection, hepato renal syndrome
Medical subject headings
Hepatitis, Alcoholic, Liver Diseases, Alcoholic, Infections, Hepatorenal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmoxicillinDrug

    Also called Amoxicillin + clavulanic acid

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

  • PlaceboDrug

    Also called Placebo of amoxicillin

    Placebo in three daily doses during 30 days

  • PrednisoloneDrug

    Also called corticotherapy

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

Study groups in NCT02281929
Study groupRoleWhat they receive
amoxicillin+ prednisoloneActive comparatorOral 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.
Receives: Drug: Amoxicillin; Drug: Prednisolone
Placebo + prednisolonePlacebo comparatorOral 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.
Receives: Drug: Placebo; Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient alive

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

    Measured: at day 60

Secondary outcomes (5)

  1. Infection

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

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

  2. Hepatorenal syndrome

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

    Measured: at day 7, day14, day 21, day 30,at 3 months, at 6 months

  3. MELD score <17

    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.

    Measured: at day 7, day14, day 21, day 30,

  4. Lille Model

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

    Measured: at day 7, after the first administration of treatment

  5. Patient alive

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

    Measured: at 3 months, at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2014 (estimated)
  2. Study start13 Jun 2015
  3. Primary completion19 Nov 2019
  4. Study completion19 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02281929
Sponsor's protocol ID
2014_05
Other IDs
2014-002536-13, PHRC-2013-0552, 2014
Acronym
AntibioCor
Status last verified
Mar 2021
First submitted
28 Oct 2014
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Mathurin P, O'Grady J, Carithers RL, Phillips M, Louvet A, Mendenhall CL, Ramond MJ, Naveau S, Maddrey WC, Morgan TR. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis: meta-analysis of individual patient data. Gut. 2011 Feb;60(2):255-60. doi: 10.1136/gut.2010.224097. Epub 2010 Oct 12.

    PubMed 20940288

  • Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.

    PubMed 22070475

  • Lucey MR, Mathurin P, Morgan TR. Alcoholic hepatitis. N Engl J Med. 2009 Jun 25;360(26):2758-69. doi: 10.1056/NEJMra0805786. No abstract available.

    PubMed 19553649

  • Louvet A, Wartel F, Castel H, Dharancy S, Hollebecque A, Canva-Delcambre V, Deltenre P, Mathurin P. Infection in patients with severe alcoholic hepatitis treated with steroids: early response to therapy is the key factor. Gastroenterology. 2009 Aug;137(2):541-8. doi: 10.1053/j.gastro.2009.04.062. Epub 2009 May 13.

    PubMed 19445945

  • Louvet A, Naveau S, Abdelnour M, Ramond MJ, Diaz E, Fartoux L, Dharancy S, Texier F, Hollebecque A, Serfaty L, Boleslawski E, Deltenre P, Canva V, Pruvot FR, Mathurin P. The Lille model: a new tool for therapeutic strategy in patients with severe alcoholic hepatitis treated with steroids. Hepatology. 2007 Jun;45(6):1348-54. doi: 10.1002/hep.21607.

    PubMed 17518367

  • Mathurin P, Louvet A, Duhamel A, Nahon P, Carbonell N, Boursier J, Anty R, Diaz E, Thabut D, Moirand R, Lebrec D, Moreno C, Talbodec N, Paupard T, Naveau S, Silvain C, Pageaux GP, Sobesky R, Canva-Delcambre V, Dharancy S, Salleron J, Dao T. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: a randomized clinical trial. JAMA. 2013 Sep 11;310(10):1033-41. doi: 10.1001/jama.2013.276300.

    PubMed 24026598

  • Louvet A, Labreuche J, Dao T, Thevenot T, Oberti F, Bureau C, Paupard T, Nguyen-Khac E, Minello A, Bernard-Chabert B, Anty R, Wartel F, Carbonell N, Pageaux GP, Hilleret MN, Moirand R, Nahon P, Potey C, Duhamel A, Mathurin P. Effect of Prophylactic Antibiotics on Mortality in Severe Alcohol-Related Hepatitis: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1558-1566. doi: 10.1001/jama.2023.4902.

    PubMed 37159035

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amoxicillin and Prednisolone in people with Alcoholic Hepatitis and Alcoholic Liver Disease, run by University Hospital, Lille at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient alive (time frame: at day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02281929, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in