Piperacillin-sulbactam versus piperacillin-tazobactam: a multicentre, randomised, single-blind, controlled clinical trial

The objective of this study was to compare the efficacy and safety of piperacillin-sulbactam (PIP-SBT) and piperacillin-tazobactam (PIP-TAZ) in the treatment of bacterial respiratory and urinary tract infections. A randomised, single-blind, controlled clinical trial was performed. Differences in clinical efficacy, bacteriology and safety between the two groups were subjected to statistical analysis, including intent-to-treat (ITT) analysis. A total of 215 cases were enrolled, with 203 complete cases (99 PIP-SBT, 104 PIP-TAZ). A total of 209 cases (103 PIP-SBT, 106 PIP-TAZ) were included in the ITT analysis and a total of 212 cases (104 PIP-SBT, 108 PIP-TAZ) were included in the safety analysis. Overall efficacy rates of PIP-SBT and PIP-TAZ were 93.2% and 93.4%, respectively. Overall bacterial eradication rates of the two groups were 95% and 97.59%, respectively. Among the PIP-SBT group, eight patients (7.69%) had adverse events, including four probable drug-related events. Among the PIP-TAZ group, nine patients (8.33%) had adverse events, including one definitely drug-related and four probable drug-related events. All differences between the two groups were insignificant. PIP-SBT could be a suitable replacement for PIP-TAZ in the therapy of community-acquired respiratory and urinary tract infections caused by β-lactamase-producing bacterial isolates.