CEFEPIME FOR INFECTIONS OF THE BILIARY-TRACT

Antibiotic treatment of biliary tract infections is widely accepted. A n 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 ra ndomized to receive gentamicin plus mezlocillin (two to one randomizat ion schedule). The diagnosis was acute cholecystitis in 101 patients a nd acute cholangitis in the remainder. There were no differences betwe en the two treatment groups with regard to gender, age, disease, signs and symptoms, admitting temperature or laboratory values. All patient s (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 a dverse events and complications were similar between the two groups (8 .8 percent for cefepime versus 10 percent for gentamicin and mezlocill in). Our data show that the efficacy and safety of cefepime administer ed every 12 hours is equivalent to that of the gentamicin and mezlocil lin combination for treating patients with acute infections of the bil iary tract. In addition, twice-daily administration of cefepime may be more cost-effective than the aminoglycoside-based combination.