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 beta-lactamase-producing bacterial isolates.
Zhiyong
Zong
Z
Department of Infectious Diseases, West China Hospital, Sichuan University, Wainan Guoxuexiang 37, Chengdu 610041, China.
Xiaoju
Lü
L
Yanbin
Liu
L
Yao
Yang
Y
Rujia
Yu
Y
Xueqin
Fu
F
Wenxiang
Huang
H
Sufang
Cai
C
Zebo
Yu
Y
Xingping
Zeng
Z
Minggang
Duan
D
Peiyuan
Xia
X
Weiming
Zhu
Z
Xianghui
Ji
J
Hongwen
Zhao
Z
Yongchuan
Chen
C
Fei
Yin
Y
Zongzan
Ni
N
D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010397:Penicillanic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D010878:Piperacillin / Q000627:therapeutic use*; D000077725:Piperacillin, Tazobactam Drug Combination; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D016037:Single-Blind Method; D013407:Sulbactam / Q000627:therapeutic use*; D014552:Urinary Tract Infections / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D000077725:Piperacillin, Tazobactam Drug Combination; D010397:Penicillanic Acid; D013407:Sulbactam; D010878:Piperacillin