Continuous versus inpatient prophylaxis of the first episode of spontaneous bacterial peritonitis with norfloxacin

Hepatology. 1997 Mar;25(3):532-6. doi: 10.1002/hep.510250306.

Abstract

Cirrhotic patients with ascites and low ascitic fluid total protein and/or high serum bilirubin levels are at high risk to develop the first episode of spontaneous bacterial peritonitis during long-term follow-up. The aim of the present study was to determine the efficacy of continuous long-term selective intestinal decontamination with norfloxacin in the prevention of this complication. One hundred nine cirrhotic patients with ascites and ascitic fluid total protein levels of < or = 1 g/dL or serum bilirubin levels of > 2.5 mg/dL without previous spontaneous bacterial peritonitis were prospectively randomized into two groups: group 1 (n = 56) received norfloxacin, 400 mg daily administered orally, and group 2 (n = 53) was the long-term control group, receiving norfloxacin only during hospitalization. During a mean follow-up of 43 +/- 3 weeks, there was one spontaneous bacterial peritonitis (1.8%) in group 1 and 9 (16.9%) in group 2 (P < .01). The incidence of community-acquired spontaneous bacterial peritonitis was lower in group 1 (1.8% vs. 13.2%, P < .05), whereas the incidence of nosocomial spontaneous bacterial peritonitis (0% vs. 3.7%) and the incidence of extraperitoneal infections (25% vs. 24.5%) were similar in both groups (P = NS). The actuarial probability of survival at 18 months was 75% in group 1 and 62% in group 2 (P = NS). Resistance to norfloxacin was observed in 9 of 10 (90%) Escherichia coli isolated in infections from group 1 and in 4 of 11 (36.3%) from group 2 (P < .05). The overall incidence of infections caused by norfloxacin-resistant bacteria was higher in group 1 (19.6% vs. 15%), but it did not reach statistical significance. Continuous long-term selective intestinal decontamination with norfloxacin is effective in preventing the first spontaneous bacterial peritonitis in cirrhotic patients at high risk. However, the emergence of infections caused by norfloxacin-resistant bacteria must be weighed carefully against the benefits of continuous long-term prophylaxis.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Anti-Infective Agents / therapeutic use*
  • Ascites / complications
  • Bacterial Infections / epidemiology
  • Bacterial Infections / microbiology
  • Bacterial Infections / prevention & control*
  • Drug Administration Schedule
  • Drug Resistance, Microbial
  • Female
  • Follow-Up Studies
  • Hospitalization
  • Humans
  • Incidence
  • Liver Cirrhosis / complications*
  • Male
  • Middle Aged
  • Norfloxacin / therapeutic use*
  • Peritonitis / epidemiology
  • Peritonitis / microbiology
  • Peritonitis / prevention & control*

Substances

  • Anti-Infective Agents
  • Norfloxacin