Cefepime for infections of the biliary tract.

Antibiotic treatment of biliary tract infections is widely accepted. An open, prospective, randomized, multicenter trial comparing cefepime (2 grams every 12 hours) with gentamicin (1.5 milligrams per kilograms every eight hours) plus mezlocillin (3 grams every four hours) for a minimum of five days was undertaken. Of the 149 patients enrolled, 120 were evaluable; 80 were randomized to receive cefepime and 40 were randomized to receive gentamicin plus mezlocillin (two to one randomization schedule). The diagnosis was acute cholecystitis in 101 patients and acute cholangitis in the remainder. There were no differences between the two treatment groups with regard to gender, age, disease, signs and symptoms, admitting temperature or laboratory values. All patients (100 percent) treated with gentamicin and mezlocillin were cured of the infection, as were 78 (97.5 percent) of the patients treated with cefepime (difference not significant). The incidence and spectrum of adverse events and complications were similar between the two groups (8.8 percent for cefepime versus 10 percent for gentamicin and mezlocillin). Our data show that the efficacy and safety of cefepime administered every 12 hours is equivalent to that of gentamicin and mezlocillin combination for treating patients with acute infections of the biliary tract. In addition, twice-daily administration of cefepime may be more cost-effective than the aminoglycoside-based combination.

RCT Entities:   Population Interventions Outcomes