UnknownPhase 2

Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis

Spain29 participantsStarted 2013-04

Plain-language summary

Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis. The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients ≥18 and \<70 years of age. * Active alcohol abuse and excessive alcohol consumption prior to admission defined as \> 50 g per day for men and\> 40 g per day for women. * Jaundice (Bilirubin \>2 mg/dl) for no more than 3 months. * Clinical suspicion of Alcoholic Hepatitis with a modified Maddrey's Discriminant Function \> 32 points. Exclusion Criteria: * Hypersensitivity to Rifaximin * Advanced Chronic or Terminal illness. Advanced Chronic illness will be defined as: all conditions evolved into a clinical stage to limit the patient's functional status (eg, heart failure NYHA\> II, COPD PCO2\> 50 mmHg or PO2 \<60 mmHg, stroke or other disabling neurological disease, disabling or uncontrolled oncological conditions, etc ...). Terminal illness will be defined as any clinical conditions with a survival expectancy less than 3 months * Hepatocellular carcinoma (previously diagnosed) beyond Milan's criteria. * Complete portal vein thrombosis (previously diagnosed). * Autoimmune liver disease. * Hepatitis B and C and HIV infection (anti-HCV, surface HBV antigen and anti-HIV positive). * Pregnancy or nursing. * Use of Rifaximin during the previous 2 months. * Treatment with Pentoxifylline. * Lack of informed consent. Removal criteria: * Lack of histological confirmation of Alcoholic Hepatitis during the first 7 days after inclusion. Because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in …

What they're measuring

Rate of bacterial infections

Timeframe: 90 days

Trial details

NCT IDNCT02116556

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12