A randomised controlled study of high dose versus standard dose antibiotics for the prevention of bacterial sepsis in advanced liver disease

Phase 2

Recruiting

• Conditions: cirrhosis; bacterial infection; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12609001076268
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patient with cirrhosis and ascites
Between 18 and 80 years of age
Able to give informed consent

Exclusion Criteria

Allergies to trimethoprim-sulfamethoxazole or sulfa
Previous documented failure of trimethoprim-sulfamethoxazole
Severe renal impairment
Hepatocellular carcinoma, malignancy or other conditions associated with expected survival of less than 3 months
Current bacterial infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of bacterial infection with diagnosis based on positive microbiological culture, documented radiological changes consistent with infection or established clinical diagnosis[Every 3 months following randomisation for 12 months];Incidence of admission to hospital for other complications of chronic liver disease based on prospective follow up and review of medical records[Every 3 months following randomisation for 12 months]