A randomized controlled clinical trial on piperacillin/tazobactam versus ticarcillin/clavulanic acid for the treatment of bacterial infections.

OBJECTIVE: To compare the efficacy and safety of two beta-lactam-beta-lactamase inhibitor combinations, piperacillin/tazobactam and ticarcillin/clavulanic acid in the treatment of bacterial infections. METHODS: A randomized, open-labeled, controlled study was conducted for the treatment of 124 hospitalized patients with lower respiratory tract infection and urinary tract infections. Sixty-three patients received piperacillin (4 g)/tazobactam (500 mg) every 8 hours by intravenous infusion and 61 patients received ticarcillin (3 g)/clavulanic acid (200 mg) every 8 hours by intravenous infusion. The duration of treatment was 7-14 days in both groups. RESULTS: Sixty-three of 79 cases who received piperacillin/tazobactam and 61 of 84 cases who received ticarcillin/clavulanic acid were assessable for clinical efficacy. The overall efficacy rates were 90.5% for the piperacillin/tazobactam group and 88.5% for the ticarcillin/clavulanic acid group, whereas the bacterial eradication rates were 90.2% and 92.0%, respectively. 78 (77.2%) of 101 strains isolated from patients produced beta-lactamases. The adverse reaction was evaluated in 65 cases of piperacillin/tazobactam group and 62 cases of ticarcillin/clavulanic acid group. The adverse drug reaction rates were 7.69% (5/65) and 8.06% (5/62), respectively. CONCLUSIONS: Piperacillin/tazobactam and ticarcillin/clavulanic acid were effective and safe for the treatment of lower respiratory tract infections and urinary tract infections caused by beta-lactamase-producing strains. The results showed that there was no statistical difference between these two groups (P > 0.05).