Norfloxacin vs ceftriaxone in the prophylaxis of infections in patients with advanced cirrhosis and hemorrhage

Gastroenterology. 2006 Oct;131(4):1049-56; quiz 1285. doi: 10.1053/j.gastro.2006.07.010.


Background & aims: Oral norfloxacin is the standard of therapy in the prophylaxis of bacterial infections in cirrhotic patients with gastrointestinal hemorrhage. However, during the last years, the epidemiology of bacterial infections in cirrhosis has changed, with a higher incidence of infections caused by quinolone-resistant bacteria. This randomized controlled trial was aimed to compare oral norfloxacin vs intravenous ceftriaxone in the prophylaxis of bacterial infection in cirrhotic patients with gastrointestinal bleeding.

Methods: One hundred eleven patients with advanced cirrhosis (at least 2 of the following: ascites, severe malnutrition, encephalopathy, or bilirubin >3 mg/dL) and gastrointestinal hemorrhage were randomly treated with oral norfloxacin (400 mg twice daily; n = 57) or intravenous ceftriaxone (1 g/day; n = 54) for 7 days. The end point of the trial was the prevention of bacterial infections within 10 days after inclusion.

Results: Clinical data were comparable between groups. The probability of developing proved or possible infections, proved infections, and spontaneous bacteremia or spontaneous bacterial peritonitis was significantly higher in patients receiving norfloxacin (33% vs 11%, P = .003; 26% vs 11%, P = .03; and 12% vs 2%, P = .03, respectively). The type of antibiotic used (norfloxacin), transfusion requirements at inclusion, and failure to control bleeding were independent predictors of infection. Seven gram-negative bacilli were isolated in the norfloxacin group, and 6 were quinolone resistant. Non-enterococcal streptococci were only isolated in the norfloxacin group. No difference in hospital mortality was observed between groups.

Conclusions: Intravenous ceftriaxone is more effective than oral norfloxacin in the prophylaxis of bacterial infections in patients with advanced cirrhosis and hemorrhage.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Aged
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Infective Agents / administration & dosage*
  • Antibiotic Prophylaxis*
  • Bacteremia / mortality
  • Bacteremia / prevention & control
  • Bacterial Infections / mortality
  • Bacterial Infections / prevention & control*
  • Ceftriaxone / administration & dosage*
  • Female
  • Gastrointestinal Hemorrhage / drug therapy*
  • Gastrointestinal Hemorrhage / etiology
  • Gastrointestinal Hemorrhage / mortality
  • Humans
  • Injections, Intravenous
  • Liver Cirrhosis / complications
  • Liver Cirrhosis / drug therapy*
  • Liver Cirrhosis / mortality
  • Male
  • Middle Aged
  • Norfloxacin / administration & dosage*
  • Peritonitis / mortality
  • Peritonitis / prevention & control
  • Risk Factors
  • Treatment Outcome


  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Ceftriaxone
  • Norfloxacin