AntibioCor
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
73.0% male
N = 284
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)
Primary outcome
Death from all causes at day 60
17.3
21.9
21.9 %
16.4 %
10.9 %
5.5 %
0.0 %
Amoxicillin/clavulanate
Placebo
No significant difference ↔
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.
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