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

Abstract

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.

Keywords: Trimethoprim-sulfamethoxazole combination; infection; liver cirrhosis; norfloxacin; prevention.