A randomized controlled study of trimethoprim‐sulfamethoxazole versus norfloxacin for the prevention of infection in cirrhotic patients

Objective To prospectively compare norfloxacin ( N ) with trimethoprim‐sulfamethoxazole ( T ‐ S ) in preventing infection in cirrhotic patients. Methods Cirrhotic patients at high risk of spontaneous bacterial peritonitis ( SBP ) were recruited and assigned N (400 mg daily) or T ‐ S (160/800 mg daily). Patients were followed up for 12 months. The primary end‐point was the incidence of infection. Secondary end‐points included the incidence of SBP , bacteremia, extraperitoneal infection requiring antibiotic treatment, liver transplantation, death, side effects and rate of resistance to N or T ‐ S . Results A total of 80 patients with a mean age of 53.0 ± 9.3 years were prescribed N ( n  = 40) or T ‐ S ( n  = 40). Child–Pugh status, model for end‐stage liver disease and risk factors for SBP were similar between the groups. There were 10 episodes of infections in the N group and 9 in the T ‐ S group ( P  = 0.79). Two patients each in the N and T ‐ S group developed SBP ( P  = 0.60). There was a difference in the rate of transplantation favoring N ( P  = 0.03) but not death. The number of adverse events for N ( n  = 7) and T ‐ S ( n  = 10) were similar ( P  = 0.59), with T ‐ S being associated with an increased risk of developing a definite or probable adverse event compared to N (22.5% vs 0%, P  = 0.01). Conclusions This study failed to demonstrate a difference between N and T ‐ S groups in their effects on preventing infection in patients with liver cirrhosis. T ‐ S can be considered an alternative first‐line therapy for infection prophylaxis.