NORFLOXACIN PRIMARY PROPHYLAXIS OF BACTERIAL-INFECTIONS IN CIRRHOTIC-PATIENTS WITH ASCITES - A DOUBLE-BLIND RANDOMIZED TRIAL

Backgrounds/Aims: Norfloxacin is useful to prevent infections in hospi talized cirrhotic patients with low ascitic fluid protein concentratio ns. It is also effective in preventing the recurrence of spontaneous b acterial peritonitis. The aim of our study was to determine the effica cy of norfloxacin in the primary prophylaxis of gram-negative bacilli infections in cirrhotic patients with low ascitic fluid protein levels (<15 g/l), Methods: One hundred and seven patients mere randomized to receive norfloxacin (400 mg/day; n=53) or placebo (n=54) for 6 months . The patients had no history of infection since cirrhosis diagnosis a nd no active infection. Results: The probability of gram-negative infe ction was significantly lon er among patients treated with norfloxacin than among those treated with placebo. Six gram-negative bacilli infe ctions occurred in the placebo group and none in the treatment group. Severe infections (spontaneous bacterial peritonitis, neutrocytic asci tes and bacteremia) developed in nine patients in the placebo group (1 7%) and in one patient in the norfloxacin group (2%; p<0.03), There wa s no between-group difference in the overall rate of infection or in s urvival, In ten patients from the norfloxacin group, gram-negative bac illi not present in baseline stool cultures were transiently isolated in follow-up cultures. Conclusions: These data show that primary proph ylaxis with norfloxacin for 6 months is effective in the prevention of infections caused by gram-negative bacilli in cirrhotic patients with low ascitic fluid total protein levels.