6/28/23, 12:52 AM AntibioCor Pathway Feedback Search Clinical Topics Home Studies AntibioCor AntibioCor Disease Disease Alcohol-related liver disease Alcoholic hepatitis Trial question What is the role of prophylactic antibiotics in patients hospitalized with severe alcohol-related hepatitis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 27.0% female N = 284 73.0% male 284 patients (78 female, 206 male) Inclusion criteria: patients hospitalized with severe alcohol-related hepatitis treated with prednisolone Key exclusion criteria: allergy/hypersensitivity to amoxicillin or clavulanic acid; history of liver injury to amoxicillin and/or clavulanic acid; phenylketonuria; severe extrahepatic disease; uncontrolled gastrointestinal bleeding Interventions N=142 amoxicillin-clavulanate (amoxicillin 1 g and clavulanate 125 mg TID plus prednisolone 40 mg/day for 30 days) N=142 placebo (matching placebo TID plus prednisolone 40 mg/day for 30 days) https://web.pathway.md/studies/rec0NMFx3SoIWKVBo 1/2 6/28/23, 12:52 AM AntibioCor Pathway Primary outcome Death from all causes at day 60 21.9 % 21.9 17.3 16.4 % 10.9 % 5.5 % No significant difference 0.0 % Amoxicillin-clavulanate Placebo No significant difference in death from all causes at day 60 (17.3% vs. 21.9%; HR 0.77, 95% CI 0.45 to 1.31) Secondary outcomes No significant difference in death from all causes at day 90 (21% vs. 26.3%; HR 0.78, 95% CI 0.47 to 1.27) Significant decrease in infection at day 60 (29.7% vs. 41.5%; HR 0.62, 95% CI 0.41 to 0.91) No significant difference in hepatorenal syndrome at day 60 (7.7% vs. 8.5%; HR 0.91, 95% CI 0.4 to 2.05) Safety outcomes No significant differences in any serious adverse event, infections, gastrointestinal disorders. Conclusion In patients hospitalized with severe alcohol-related hepatitis treated with prednisolone, amoxicillin- clavulanate was not superior to placebo with respect to death from all causes at day 60. Reference Alexandre Louvet, Julien Labreuche, Thong Dao et al. Effect of Prophylactic Antibiotics on Mortality in Severe Alcohol-Related Hepatitis: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1558- 1566. Open reference URL https://web.pathway.md/studies/rec0NMFx3SoIWKVBo 2/2