Gastroenterology

Gastroenterology

Volume 131, Issue 4, October 2006, Pages 1049-1056
Gastroenterology

Clinical–liver, pancreas, and biliary tract
Norfloxacin vs Ceftriaxone in the Prophylaxis of Infections in Patients With Advanced Cirrhosis and Hemorrhage

https://doi.org/10.1053/j.gastro.2006.07.010Get rights and content

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. Nonenterococcal 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.

Section snippets

Patients

The study was performed in patients with cirrhosis admitted to 4 Spanish hospitals for the treatment of an upper gastrointestinal hemorrhage between February 2000 and April 2004. Diagnosis of cirrhosis was based on clinical, laboratory, and ultrasonographic data or on histology. Inclusion criteria were as follows: age 18–80 years, hematemesis and/or melena within 24 hours prior to inclusion, and advanced cirrhosis as defined by the presence of 2 or more of the following signs of liver failure:

Results

A total of 1369 cirrhotic patients with gastrointestinal hemorrhage were screened. Of these, 1245 patients were not included because of absence of 2 signs of advanced liver failure (884 patients), presence of infection at admission (253 patients), presence of advanced hepatocellular carcinoma or other neoplasia (106 patients), antibiotic treatment other than oral norfloxacin at admission (54 patients), age over 80 years (21 patients), HIV infection (19 patients), and other causes including

Discussion

The results of the current study confirm that patients with cirrhosis, gastrointestinal hemorrhage, and advanced liver failure are at great risk of developing bacterial infections. Despite the prophylactic administration of antibiotics, 25 of the 111 patients (23%) included in the study developed bacterial infections within 10 days after inclusion. In 8 patients, the infection was severe (spontaneous bacteremia or spontaneous bacterial peritonitis).

An important finding of the current study is

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    Supported in part by grants from the Fondo de Investigación Sanitaria (FIS 00/0921) and the Instituto de Salud Carlos III (BEFI 00/9380 and C03/02).

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