A multi-centric randomized controlled trial of sequential intravenous moxifloxacin in comparison to cefoperazone-sulbactam for the treatment of acute biliary tract infection / 中华普通外科杂志

ABSTRACT

ObjectiveTo compare the efficacy and safety of sequential intravenous moxifloxacin treatment against cefoperazone/sulbactam in patients with acute biliary tract infection. MethodsA prospective, randomized, non-blind, multi-centric study was performed to compare the efficacy and safety of moxifloxacin 400 mg Ⅳ once daily to cefoperazone-sulbactam (2 g q12 hours) and metronidazole 250 ml once daily to treat patients, from March- December 2009 in 13 hospitals, with acute biliary tract infection.The primary efficacy variable was clinical cure rate after the end of a 5 - 14 day treatment period,bacteriologic outcomes and adverse reaction effects were also determined.ResultsA total of 319 subjects were enrolled, 282 of whom were eligible for protocol efficacy analyses ( 138 moxifloxacin, 144 comparator).Demographic and baseline medical characteristics were similar between the 2 groups. Clinical success rates were 86.2％ for moxifloxacin and 84. 7％ for the comparator(P =0. 7192). Pathogens (55 moxifloxacin, 61 comparator) were isolated from bile or blood cultures and the predominant strains were E. coli, Klebsiella species and Enterococcus species. Bacterial eradication rates were 85.4％ ( 37 of 55 ) with moxifloxacin versus 82. 0％ (50 of 61 ) in the comparator group ( x2 = 0. 2568, P = 0. 6123 ). Both treatments were safe and well tolerated. ConclusionsE. coli, Klebsiella species and Enterococcus species were the most common bacteria isolated from bile or blood from patients with acute biliary tract infection. Moxifloxacin monotherapy has high clinical and bacteriological efficacies and safety for the treatment of acute biliary tract infection.