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
All-cause mortality 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 all-cause mortality at day 60 (17.3% vs. 21.9%; HR 0.77, 95% CI 0.45 to 1.31).
Secondary outcomes
No significant difference in all-cause mortality 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 all-cause mortality 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