Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone
Status:
Completed
Trial end date:
2019-11-19
Target enrollment:
Participant gender:
Summary
Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for
28 days. However, about 25-35% of patients do not take benefit from this treatment and die
within the 6 months following the diagnosis. Numerous trials have evaluated the impact of
several strategies in association with corticosteroids. None of them has shown an improvement
in survival (primary endpoint) as compared to corticosteroids alone.
The project is based on an approach never tested in a randomized controlled trial in severe
alcoholic hepatitis, targeting the group of patients at high risk of death (25-35% at 2
months). This approach is based on animal and human studies.Antibiotics are effective in
animal models and in other circumstances characterized by liver failure such as
gastrointestinal bleeding related to portal hypertension. The interest of studying this
population is emphasized by the frequency of infections in these critically ill patients.
Antibiotics will be administered before the development of any infection, as it is likely
that these patients present with mesenteric bacterial adenitis without systemic signs of
infection. Primary endpoint will be 2-month survival as most deaths occur within 60 days and
treatment is given for 30 days.