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


METHODS
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.
Sirvent
Josep Maria
JM
Servicio de Medicina Intensiva. Hospital Universitari de Girona Doctor Josep Trueta. Girona. Spain.
Rodríguez
José Ignacio
JI
Rodríguez
Isabel
I
García-Oria
Miguel
M
Roig
Josep
J
Bonet
Alfons
A
D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001649:Bile Duct Diseases / Q000188:drug therapy* / Q000382:microbiology*; D002443:Ceftriaxone / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007239:Infections / Q000188:drug therapy*; D008297:Male; D010397:Penicillanic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use*; D010878:Piperacillin / Q000627:therapeutic use*; D000077725:Piperacillin, Tazobactam Drug Combination; D011446:Prospective Studies
D000900:Anti-Bacterial Agents; D000077725:Piperacillin, Tazobactam Drug Combination; D002443:Ceftriaxone; D010397:Penicillanic Acid; D010878:Piperacillin