Effects of rifaximin administration in patients with severe acute alcoholic hepatitis. Comparative pilot study.

Conditions: Acute alcoholic hepatitis
MedDRA version: 14.1Level: LLTClassification code 10000649Term: Acute alcoholic hepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2012-000515-80-ES

Lead Sponsor: Juan Córdoba

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Patients> 18 and <70 years of age.
- Excessive alcohol consumption prior to admission.
- Jaundice in the last 3 months.
- Modified Maddrey index> 32.
- Confirmation of acute alcoholic hepatitis histology defined in the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Advanced or terminal chronic illness
- Hepatocarcinoma
- Complete portal thrombosis.
- Autoimmune liver disease.
- Infection with hepatitis B and C, or HIV.
- Use of rifaximin in the last 2 months.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether the administration of rifaximin as an adjunct to corticosteroids decreases the number of bacterial infections in patients 90 days with acute alcoholic hepatitis.;Secondary Objective: - Effect of rifaximin in the response to corticosteroids after 7 days<br>- Serum levels of endotoxemia and proinflammatory cytokines and chemotactic (chemokines)<br>- Type of infections developed within the hospital, 30 and 90 days<br>- Frequency and type of other complications of liver failure;Primary end point(s): bacterial infections;Timepoint(s) of evaluation of this end point: During hospitalization, 30 and 90 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): response to specific treatment and complications;Timepoint(s) of evaluation of this end point: at 7 days, and during hospitalization, 30 and 90 days