None listed
Conditions
Brief summary
Patients with advanced liver disease and ascites (intra-abdominal fluid) are at high risk of bacterial infections such as spontaneous bacterial peritonitis. Once daily antibiotics such as trimethoprim-sulfamethoxazole is considered standard treatment to prevent bacterial infections in this setting. However, breakthrough infections are still common. The study hypothesis is that a higher dose of antibiotics may be more effective in preventing bacterial infections in advanced liver disease. The purpose is therefore to conduct a trial to examine whether twice daily trimethoprim-sulfamethoxazole is more effective than the standard once daily dose at reducing bacterial infections and admissions to hospital in these high risk patients.
Interventions
Treatment with high dose (twice daily) trimethoprim-sulfamethoxazole 160mg-800mg oral tablet for 12 months to prevent bacterial infections in patients with cirrhosis
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
Outcome results
None listed