Estudio comparativo, prospectivo y aleatorizado de piperacilina/tazobactam frente a ceftriaxona y ornidazol en el tratamiento de las infecciones de las vías biliares

Abstract

The treatment of biliary tract infections requires antibiotics and an appropriate surgical procedure. The aim of this study was to evaluate the efficacy and safety of piperacillin/tazobactam versus ceftriaxone plus ornidazole in the treatment of biliary tract infections. This was a randomized, prospective and comparative clinical trial of two antibiotic regimens in the treatment of biliary tract infection. One hundred and fifty three patients were randomly allocated into two groups; three patients were excluded after randomization. One group (n = 75) received piperacillin/tazobactam (4 g/8 h iv) and the other group (n = 75) was administered a combination of ceftriaxone (2 g/24 h iv) plus ornidazole (1 g/24 h iv). In both groups, protocolized surgical or endoscopic procedures were carried out. Clinical efficacy and safety were assessed at the end of treatment. Demographic data and severity of disease were similar in both groups. Three patients were excluded of the study by deviations from the protocol. Sixty-seven patients (89.3%) out of the piperacillin/tazobactam group and sixty-six patients (88%) out of the ceftriaxone plus ornidazole group were clinically cured (OR = 0.87 [95% CI, 0.31-2.4]). Twelve patients died, seven in the piperacillin/tazobactam group and five in the ceftriaxone plus ornidazole group. Adverse events were similar in both groups (OR = 1.18 [95% CI, 0.37-3.7]). This study suggests that piperacillin/tazobactam is as efficacious and safe as ceftriaxone plus ornidazole in the treatment of biliary tract infections.