17 May 2023 • Adding prophylactic antibiotic therapy to prednisolone does not improve survival in patients hospitalized with severe alcohol-related hepatitis, new research published shows. This was published in JAMA Network on the 17th of May. In a double-blind randomized clinical trial, amoxicillin-clavulanate added to prednisolone did not significantly reduce all-cause mortality at 60 days compared with prednisolone alone.

STUDY RESULTS

• Patients were randomly assigned to receive prednisolone combined with amoxicillin-clavulanate (n = 145) or prednisolone combined with placebo (n = 147).
• The primary outcome was all-cause mortality at 60 days. Secondary outcomes were all-cause mortality at 90 and 180 days
• 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)
• Infection rates at 60 days were significantly lower in the amoxicillin-clavulanate group (29.7% vs 41.5%)
• 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).

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.

Source: JAMA Network | Read full story