Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone
NCT ID: NCT02281929
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
297 participants
INTERVENTIONAL
2015-06-13
2019-11-19
Brief Summary
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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.
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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amoxicillin+ 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.
Amoxicillin
Amoxicillin+clavulanic acid at a daily dose of 3 gram / 375 mg in three daily doses of 1g/125mg, during 30 days
Prednisolone
Prednisolone at 40 mg/j in a single daily dose in the morning, during 30 days
Placebo + prednisolone
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.
Placebo
Placebo in three daily doses during 30 days
Prednisolone
Prednisolone at 40 mg/j in a single daily dose in the morning, during 30 days
Interventions
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Amoxicillin
Amoxicillin+clavulanic acid at a daily dose of 3 gram / 375 mg in three daily doses of 1g/125mg, during 30 days
Placebo
Placebo in three daily doses during 30 days
Prednisolone
Prednisolone at 40 mg/j in a single daily dose in the morning, during 30 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Mathurin Philippe, MD,PhD
Role: STUDY_CHAIR
University Hospital, Lille
Locations
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CHU d'Amiens
Amiens, , France
CHU
Angers, , France
CHU de Besançon
Besançon, , France
Hôpital Jean Verdier (AH-HP)
Bondy, , France
CHU de Caen
Caen, , France
Hôpital BEaujon (AP-HP)
Clichy, , France
Centre hospitalier
Dunkirk, , France
CHU Grenoble
Grenoble, , France
Hôpital Claude Huriez, CHU
Lille, , France
CHU Montpellier
Montpellier, , France
CHU Nantes
Nantes, , France
CHU Nice
Nice, , France
Hôpital Saint Antoine (AP-HP)
Paris, , France
Hôpital La Pitié (AP-HP)
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Pontchaillou
Rennes, , France
CHU
Rouen, , France
CHU
Toulouse, , France
Centre Hospitalier
Valenciennes, , France
Hôpital Paul Brousse (AH-HP)
Villejuif, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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2014-002536-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PHRC-2013-0552
Identifier Type: OTHER
Identifier Source: secondary_id
2014_05
Identifier Type: -
Identifier Source: org_study_id