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

Author(s): Zhiyong Z, Xiaoju L, Yanbin L, Yao Y, Rujia Y, Xueqin F, Wenxiang H, Sufang C, Zebo Y, Xingping Z, Minggang D, Peiyuan X, Weiming Z, Xianghui J, Hongwen Z, Yongchuan C, Fei Y, Zongzan N

Affiliation(s): Department of Infectious Diseases, West China Hospital, Sichuan University, Wainan Guoxuexiang 37, Chengdu 610041, China.

Publication date & source: 2005-07, Int J Antimicrob Agents., 26(1):22-7.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled 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 beta-lactamase-producing bacterial isolates.

Page last updated: 2006-01-31

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