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

• Published in: International journal of antimicrobial agents Vol. 26; no. 1; pp. 22 - 27
• Main Authors: Zhiyong, Zong, Xiaoju, Lü, Yanbin, Liu, Yao, Yang, Rujia, Yu, Xueqin, Fu, Wenxiang, Huang, Sufang, Cai, Zebo, Yu, Xingping, Zeng, Minggang, Duan, Peiyuan, Xia, Weiming, Zhu, Xianghui, Ji, Hongwen, Zhao, Yongchuan, Chen, Fei, Yin, Zongzan, Ni
• Format: Journal Article
• Language: English
• Published: London Elsevier B.V 01.07.2005; Amsterdam Elsevier; New York, NY
• Subjects: Adult; Anti-Bacterial Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Bacterial infection; Biological and medical sciences; Drug Combinations; Female; Humans; Male; Medical sciences; Middle Aged; Penicillanic Acid - analogs & derivatives; Penicillanic Acid - therapeutic use; Pharmacology. Drug treatments; Piperacillin; Piperacillin - therapeutic use; RCT; Respiratory Tract Infections - drug therapy; Single-Blind Method; Sulbactam; Sulbactam - therapeutic use; Tazobactam; Urinary Tract Infections - drug therapy; Bacterial infection; RCT; Tazobactam; Sulbactam; Piperacillin; Human; Enzyme; β-Lactams; Enzyme inhibitor; β-Lactamase; Penicillin derivatives; Antibiotic; Randomization; Hydrolases; Clinical trial; Antibacterial agent; Comparative study
• ISSN: 0924-8579; 1872-7913
• DOI: 10.1016/j.ijantimicag.2005.02.018

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.