[Randomized, prospective and comparative clinical trial of piperacillin/tazobactam versus ceftriaxone plus ornidazole in the treatment of biliary tract infections]

Author(s): Sirvent JM, Rodriguez JI, Rodriguez I, Garcia-Oria M, Roig J, Bonet A

Affiliation(s): Servicio de Medicina Intensiva. Hospital Universitari de Girona Doctor Josep Trueta. Girona. Spain.

Publication date & source: 2003-12-06, Med Clin (Barc)., 121(20):761-5.

Publication type: Clinical Trial; Randomized Controlled Trial

BACKGROUND AND OBJECTIVE: 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. PATIENTS AND METHOD: 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. RESULTS: 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]). CONCLUSIONS: This study suggests that piperacillin/tazobactam is as efficacious and safe as ceftriaxone plus ornidazole in the treatment of biliary tract infections.