Rifaximin to reduce infection in decompensated cirrhosis

Not Applicable

Completed

• Conditions: Decompensated cirrhosis; Digestive System

• Registration Number: ISRCTN10994757
• Lead Sponsor: Imperial College London

Brief Summary

2021 Thesis results in https://doi.org/10.25560/97104 (added 30/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-08
• Study Completion: 2020-01-30
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of secondary or recurrent infections in patients with cirrhosis during hospitalisation or after hospital discharge is assessed using clinical evaluations at baseline, 3, 7, 14, 28 and 90 days, at 6 months (EoT) and at 9 and 12 months.

Secondary Outcome Measures

Name	Time	Method
1. Extrahepatic organ failure (e.g. renal, neurological) rate is measured by reviewing patient notes at baseline, 3, 7, 14, 28 and 90 days, at 6 months (EoT) and at 9 and 12 months<br>2. Mortality rate is measured by reviewing patient notes at baseline, 3, 7, 14, 28 and 90 days, at 6 months (EoT) and at 9 and 12 months<br>3. Readmission with sepsis rates is measured by reviewing patient notes at baseline, 3, 7, 14, 28 and 90 days, at 6 months (EoT) and at 9 and 12 months<br>4. Length of hospital stay is measured by reviewing patient notes at baseline, 3, 7, 14, 28 and 90 days, at 6 months (EoT) and at 9 and 12 months