{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T03:51:38Z","timestamp":1792295498575,"version":"4.4.0"},"reference-count":20,"publisher":"American Medical Association (AMA)","issue":"18","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2023,5,9]]},"abstract":"<jats:sec><jats:title>Importance<\/jats:title><jats:p>The benefits of prophylactic antibiotics for hospitalized patients with severe alcohol-related hepatitis are unclear.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine the efficacy of amoxicillin-clavulanate, compared with placebo, on mortality in patients hospitalized with severe alcohol-related hepatitis and treated with prednisolone.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>Multicenter, randomized, double-blind clinical trial among patients with biopsy-proven severe alcohol-related hepatitis (Maddrey function score \u226532 and Model for End-stage Liver Disease [MELD] score \u226521) from June 13, 2015, to May 24, 2019, in 25 centers in France and Belgium. All patients were followed up for 180 days. Final follow-up occurred on November 19, 2019.<\/jats:p><\/jats:sec><jats:sec><jats:title>Intervention<\/jats:title><jats:p>Patients were randomly assigned (1:1 allocation) to receive prednisolone combined with amoxicillin-clavulanate (n\u2009=\u2009145) or prednisolone combined with placebo (n\u2009=\u2009147).<\/jats:p><\/jats:sec><jats:sec><jats:title>Main Outcome and Measures<\/jats:title><jats:p>The primary outcome was all-cause mortality at 60 days. Secondary outcomes were all-cause mortality at 90 and 180 days; incidence of infection, incidence of hepatorenal syndrome, and proportion of participants with a MELD score less than 17 at 60 days; and proportion of patients with a Lille score less than 0.45 at 7 days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 292 randomized patients (mean age, 52.8 [SD, 9.2] years; 80 [27.4%] women) 284 (97%) were analyzed. There was no significant difference in 60-day mortality between participants randomized to amoxicillin-clavulanate and those randomized to placebo (17.3% in the amoxicillin-clavulanate group and 21.3% in the placebo group [<jats:italic>P<\/jats:italic>\u2009=\u2009.33]; between-group difference, \u22124.7% [95% CI, \u221214.0% to 4.7%]; hazard ratio, 0.77 [95% CI, 0.45-1.31]). Infection rates at 60 days were significantly lower in the amoxicillin-clavulanate group (29.7% vs 41.5%; mean difference, \u221211.8% [95% CI, \u221223.0% to \u22120.7%]; subhazard ratio, 0.62; [95% CI, 0.41-0.91]; <jats:italic>P<\/jats:italic>\u2009=\u2009.02). There were no significant differences in any of the remaining 3 secondary outcomes. The most common serious adverse events were related to liver failure (25 in the amoxicillin-clavulanate group and 20 in the placebo group), infections (23 in the amoxicillin-clavulanate group and 46 in the placebo group), and gastrointestinal disorders (15 in the amoxicillin-clavulanate group and 21 in the placebo group).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion and Relevance<\/jats:title><jats:p>In patients hospitalized with severe alcohol-related hepatitis, amoxicillin-clavulanate combined with prednisolone did not improve 2-month survival compared with prednisolone alone. These results do not support prophylactic antibiotics to improve survival in patients hospitalized with severe alcohol-related hepatitis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02281929\">NCT02281929<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jama.2023.4902","type":"journal-article","created":{"date-parts":[[2023,5,9]],"date-time":"2023-05-09T21:44:21Z","timestamp":1683668661000},"page":"1558","source":"Crossref","is-referenced-by-count":76,"title":["Effect of Prophylactic Antibiotics on Mortality in Severe Alcohol-Related Hepatitis"],"prefix":"10.1001","volume":"329","author":[{"given":"Alexandre","family":"Louvet","sequence":"first","affiliation":[{"name":"Universit\u00e9 Lille, CHU de Lille, Service des maladies de l\u2019appareil digestif, H\u00f4pital 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