Amoxicillin-clavulanic acid versus cefotaxime in the therapy of bacterial infections in cirrhotic patients

J Hepatol. 2000 Apr;32(4):596-602. doi: 10.1016/s0168-8278(00)80221-4.

Abstract

Background/aim: Cefotaxime is considered the first-choice antibiotic for empirical treatment in cirrhotic patients developing bacterial infections. It has been suggested that amoxicillin-clavulanic acid could be an alternative to cefotaxime, particularly in patients developing bacterial infections while on prophylactic norfloxacin. The aim of the present study was to compare amoxicillin-clavulanic acid with cefotaxime in the treatment of bacterial infections in cirrhosis.

Methods: Ninety-six hospitalized cirrhotic patients with suspicion of bacterial infection were prospectively included and randomized into two groups: one group (n=48) received amoxicillin-clavulanic acid, first intravenously 1 g-0.2 g every 8 h, and then orally 500 mg-125 mg every 8 h, and the other group (n=48) received intravenous cefotaxime 1 g every 6 h. Patients were stratified for previous prophylaxis with norfloxacin and ascitic fluid infection.

Results: Sixteen patients were excluded from the analysis because bacterial infection was not demonstrated or because of secondary peritonitis. Therefore, 38 patients from the amoxicillin-clavulanic acid group and 42 from the cefotaxime group were finally analyzed. There were 24 ascitic fluid infections in each group. Infection resolution (86.8% vs 88%, 95% CI: -0.15 to 0.13, p NS), spontaneous bacterial peritonitis resolution (87.5% vs 83.3%, 95% CI: -0.15 to 0.24, p NS), duration of treatment, incidence of complications, time of hospitalization and hospital mortality were similar in both groups. Considering patients on prophylactic norfloxacin, infection resolution was also similar (100% vs 83.3%, 95% CI: -0.04 to 0.37, p NS). No adverse events were observed in either of the two groups. The cost of antibiotics was statistically lower in the amoxicillin-clavulanic acid group (p<0.001).

Conclusions: Amoxicillin-clavulanic acid is as effective as cefotaxime in the treatment of bacterial infections in cirrhotic patients, but is less expensive and can be administered orally. These results suggest that amoxicillin-clavulanic acid is an effective alternative to cefotaxime for the empirical treatment of bacterial infections in cirrhosis.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Amoxicillin / administration & dosage*
  • Anti-Bacterial Agents / administration & dosage*
  • Bacterial Infections / drug therapy*
  • Bacterial Infections / etiology
  • Cefotaxime / administration & dosage*
  • Cephalosporins / administration & dosage*
  • Clavulanic Acid / administration & dosage*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Liver Cirrhosis / complications*
  • Male
  • Middle Aged
  • Penicillins / administration & dosage*
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Cephalosporins
  • Penicillins
  • Clavulanic Acid
  • Amoxicillin
  • Cefotaxime