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

INTERVENTION: Treatment with high dose (twice daily) trimethoprim‐sulfamethoxazole 160mg‐800mg oral tablet for 12 months to prevent bacterial infections in patients with cirrhosis CONDITION: bacterial infection cirrhosis PRIMARY OUTCOME: Incidence of admission to hospital for other complications of chronic liver disease based on prospective follow up and review of medical records Incidence of bacterial infection with diagnosis based on positive microbiological culture, documented radiological changes consistent with infection or established clinical diagnosis SECONDARY OUTCOME: Mortality rate based on prospective follow up and review of medical records Rate of bacteraemia based on positive microbiological culture or established clinical diagnosis Rate of extraperitoneal infection requiring antibiotic therapy based on positive microbiological culture, documented radiological changes consistent with infection or established clinical diagnosis Rate of hepatorenal syndrome based on blood and urine analysis meeting established diagnostic criteria Rate of peritoneal bacterial infection requiring antibiotic therapy based on positive microbiological culture or elevated white blood cell/neutrophil count consistent with established diagnostic criteria Resistance rates to trimethoprim‐sulfamethoxazole in organisms isolated during the study based on documented event of infection and proven resistance on microbiological culture and sensitivity testing. Side effects and tolerability of trimethoprim‐sulfamethoxazole daily and twice daily. Possible side effects include nausea, loss of appetite, rash, abnormal cell counts and elevated potassium levels. This will be assessed by interview of patient and review of blood tests. INCLUSION CRITERIA: Patient with cirrhosis and ascites Between 18 and 80 years of age Able to give informed consent