Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis (RIFA-AAH)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study|
- Rate of bacterial infections [ Time Frame: 90 days ] [ Designated as safety issue: No ]Development of any bacterial infection.
- Rate of Decompensations of Liver Cirrhosis [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Development of any liver cirrhosis decompensations
- Hepatic Encephalopathy
- Acute Kidney Injury (including Hepatorenal Syndrome)
- Acute variceal bleeding
- Endotoxemia serum levels [ Time Frame: 90 days ] [ Designated as safety issue: No ]Measurement of serum changes in endotoxemia levels during the rifaximin treatment.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Prednisone
Prednisone PO 40mg/day for 30 days plus standard supportive care measurements
Prednisone PO 40mg/day or IV equivalent dosage for 30 days. Patients not responding at 7 days (e.g. Lille Model ≥ 0.45) treatment with Prednisone will be suspended.
Experimental: Prednisone plus Rifaximin
Prednisone PO 40mg/day for 30 days plus Rifaximin PO 1200 mg/day for 90 days plus standard supportive care measurements
Prednisone PO 40mg/day or IV equivalent dosage for 30 days. Patients not responding at 7 days (e.g. Lille Model ≥ 0.45) treatment with Prednisone will be suspended.Drug: Rifaximin
Rifaximin PO 1200 mg/day for 90 days
Design: Open multicenter comparative study. A cohort (n = 66) will receive rifaximin (1200 mg / d) for 90 days. Results will be compared with those of a cohort of AAH prospectively included in an observational study. Both groups with a uniform treatment protocol (which includes the administration of corticosteroids and standardized treatment for complications of liver failure). Patients will be monitorized until hospital discharge and a follow-up visit at 7, 30, 45, 60 and 90 days will be performed.
- Primary endpoint: Bacterial infections after 90 days.
- Secondary endpoints: :
2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival
Please refer to this study by its ClinicalTrials.gov identifier: NCT02116556
|Contact: Victor Vargas, MDfirstname.lastname@example.org|
|Contact: Joan Genescà, MDemail@example.com|
|Vall d'Hebron Hospital||Recruiting|
|Hospital del Mar||Recruiting|
|Hospital Clinic||Active, not recruiting|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Hospital Universitari Germans Trias i Pujol||Recruiting|
|Principal Investigator:||Victor Vargas, MD||Internal Medicine Service. Vall d'Hebron Hospital|