title: Ertapenem versus piperacillin/tazobactam for diabetic foot infections in China: a Phase 3, multicentre, randomized, double-blind, active-controlled, non-inferiority trial.
abstract: Few randomized controlled studies have compared antibiotic regimens against diabetic foot infections (DFIs) in Chinese patients. We evaluated the efficacy and safety of ertapenem versus piperacillin/tazobactam for the treatment of DFIs in Chinese patients.
  
  
  
  Patients with moderate to severe DFIs requiring parenteral antibiotics were randomized in a 1 : 1 ratio to receive ertapenem (1.0 g once daily) or piperacillin/tazobactam (4.5 g every 8 h) by 30 min intravenous (iv) infusions for ≥5 days. The primary outcome was favourable clinical response at discontinuation of iv therapy (DCIV). An evaluable-patient population was identified for primary analysis of non-inferiority at -15%. Safety was assessed. ClinicalTrials.gov: NCT01370616.
  
  
  
  Of 565 patients randomized, 443 patients (ertapenem = 219 and piperacillin/tazobactam = 224) were clinically evaluable for primary analysis. In the clinically evaluable population, the proportions of patients with favourable clinical response at DCIV were 93.6% (205/219) and 97.3% (218/224) in the ertapenem and piperacillin/tazobactam groups, respectively (difference: -3.8%, 95% CI: -8.3%, 0.0%). Ertapenem had a significantly lower favourable clinical response rate (91.5% versus 97.2%, 95% CI for difference: -12.1%, -0.3%) at DCIV in severe DFI patients. In the modified ITT population, 88.8% (237/267) and 90.6% (241/266) of patients in the ertapenem and piperacillin/tazobactam groups, respectively, had favourable clinical responses at DCIV (difference: -1.9%, 95% CI: -7.3%, 3.3%). Microbiological eradications of causative pathogens and adverse events were similar between treatment groups.
  
  
  
  Treatment with ertapenem was non-inferior to piperacillin/tazobactam in Chinese patients with DFIs. Ertapenem treatment resulted in a markedly lower rate of clinical resolution in severe DFIs.
authors.affiliation: The 306th Hospital, Beijing 100101, China xzr1021@vip.sina.com.
authors.forename: Zhang-Rong
authors.initials: ZR
authors.lastname: Xu
authors.affiliation: West China Hospital, Sichuan University, Chengdu, China.
authors.forename: Xing-Wu
authors.initials: XW
authors.lastname: Ran
authors.affiliation: Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Xian
authors.affiliation: The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
authors.forename: Xiao-Dong
authors.initials: XD
authors.lastname: Yan
authors.affiliation: Affiliated Hospital of Jiangsu University, Zhenjiang, China.
authors.forename: Guo-Yue
authors.initials: GY
authors.lastname: Yuan
authors.affiliation: MSD China, Shanghai, China.
authors.forename: Sheng-Mei
authors.initials: SM
authors.lastname: Mu
authors.affiliation: MSD China, Shanghai, China.
authors.forename: Ju-Fang
authors.initials: JF
authors.lastname: Shen
authors.affiliation: MSD China, Shanghai, China.
authors.forename: Bo-Shao
authors.initials: BS
authors.lastname: Zhang
authors.affiliation: Biostatistics, PAREXEL International, Shanghai, China.
authors.forename: Wei-Jin
authors.initials: WJ
authors.lastname: Gan
authors.affiliation: MSD China, Shanghai, China.
authors.forename: Jue
authors.initials: J
authors.lastname: Wang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002681:China; D017719:Diabetic Foot / Q000150:complications*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D000077727:Ertapenem; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010397:Penicillanic Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010878:Piperacillin / Q000009:adverse effects / Q000627:therapeutic use; D000077725:Piperacillin, Tazobactam Drug Combination; D016896:Treatment Outcome; D055815:Young Adult; D065093:beta-Lactamase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D047090:beta-Lactams / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D065093:beta-Lactamase Inhibitors; D047090:beta-Lactams; D000077725:Piperacillin, Tazobactam Drug Combination; D010397:Penicillanic Acid; D000077727:Ertapenem; D010878:Piperacillin