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

A multi-centre, double-blind, randomised, controlled clinical trial of Rifaximin to reduce infection in patients admitted to hospital with decompensated cirrhosis - R-RID - Rifaximin to Reduce Infection in Decompensated Cirrhosis

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002628-96-GB

Enrollment

268

Registered

2016-08-23

Start date

2016-09-21

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompensated cirrhosis - liver disease

Interventions

Trade Name: TARGAXAN Product Name: TARGAXAN Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Rifaximin CAS Number: 80621-81-4 Current Sponsor code: UK/H/4662/001/DC Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Can Rifaximin reduce the infection rate in patients admitted to hospital with decompensated cirrhosis?;Secondary Objective: • To look at the role of Rifaxmin in decompensated liver disease: is there a role in reducing bacterial DNA and inflammatory responses?; • To greater understand immuneparesis and infection susceptibility in acute-on-chronic liver failure; • To perform metabolic profiling in decompensated liver disease. ;Primary end point(s): To evaluate whether Rifaximin reduces the infection rate in patients admitted to hospital with decompensated cirrhosis;Timepoint(s) of evaluation of this end point: Nested analysis mid way through study when 50% of patients recruited (estimate 12 months). Final analysis after last patient last visit.	—

Measure

Time frame

Main Objective: Can Rifaximin reduce the infection rate in patients admitted to hospital with decompensated cirrhosis?;Secondary Objective: • To look at the role of Rifaxmin in decompensated liver disease: is there a role in reducing bacterial DNA and inflammatory responses?; • To greater understand immuneparesis and infection susceptibility in acute-on-chronic liver failure; • To perform metabolic profiling in decompensated liver disease. ;Primary end point(s): To evaluate whether Rifaximin reduces the infection rate in patients admitted to hospital with decompensated cirrhosis;Timepoint(s) of evaluation of this end point: Nested analysis mid way through study when 50% of patients recruited (estimate 12 months). Final analysis after last patient last visit.

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Countries

United Kingdom

Contacts

Public ContactDr Harry Antoniades

Imperial College London

c.antoniades@imperial.ac.uk02033126454

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026