Does Rifaximin reduce the risk of infection for patients admitted to hospital with liver disease?

Phase 1

• Conditions: Decompensated cirrhosis - liver disease; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-002628-96-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-23
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

- Clinical/biochemical/radiological +/- histological diagnosis of cirrhosis
- Hospital admission with complication of cirrhosis (e.g. alcoholic hepatitis,sepsis, variceal bleeding)
- Commencement on antimicrobial therapy
- Age 18 – 80 years

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

- C.difficile infection
- HIV antibody positive
- Immunosuppression (excluding low dose steroids/steroid sparing agents for AIH <20mg or equivalent of prednisolone)
- Advanced disseminated Hepatocellular Carcinoma or invasive carcinoma
- eGFR <30 on screening/randomisation
- End-stage/severe cardiac, pulmonary or kidney disease
- IDDM
- Colitis or coeliac disease
- Pregnancy
- Already receiving Rifamixin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified