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Ertapenem versus piperacillin/tazobactam for diabetic foot infections in China: a Phase 3, multicentre, randomized, double-blind, active-controlled, non-inferiority trial.
J Antimicrob Chemother. 2016 06; 71(6):1688-96.JA

Abstract

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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+Show Affiliations

The 306th Hospital, Beijing 100101, China xzr1021@vip.sina.com.West China Hospital, Sichuan University, Chengdu, China.Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu, China.The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.Affiliated Hospital of Jiangsu University, Zhenjiang, China.MSD China, Shanghai, China.MSD China, Shanghai, China.MSD China, Shanghai, China.Biostatistics, PAREXEL International, Shanghai, China.MSD China, Shanghai, China.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26888908

Citation

Xu, Zhang-Rong, et al. "Ertapenem Versus Piperacillin/tazobactam for Diabetic Foot Infections in China: a Phase 3, Multicentre, Randomized, Double-blind, Active-controlled, Non-inferiority Trial." The Journal of Antimicrobial Chemotherapy, vol. 71, no. 6, 2016, pp. 1688-96.
Xu ZR, Ran XW, Xian Y, et al. Ertapenem versus piperacillin/tazobactam for diabetic foot infections in China: a Phase 3, multicentre, randomized, double-blind, active-controlled, non-inferiority trial. J Antimicrob Chemother. 2016;71(6):1688-96.
Xu, Z. R., Ran, X. W., Xian, Y., Yan, X. D., Yuan, G. Y., Mu, S. M., Shen, J. F., Zhang, B. S., Gan, W. J., & Wang, J. (2016). Ertapenem versus piperacillin/tazobactam for diabetic foot infections in China: a Phase 3, multicentre, randomized, double-blind, active-controlled, non-inferiority trial. The Journal of Antimicrobial Chemotherapy, 71(6), 1688-96. https://doi.org/10.1093/jac/dkw004
Xu ZR, et al. Ertapenem Versus Piperacillin/tazobactam for Diabetic Foot Infections in China: a Phase 3, Multicentre, Randomized, Double-blind, Active-controlled, Non-inferiority Trial. J Antimicrob Chemother. 2016;71(6):1688-96. PubMed PMID: 26888908.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ertapenem versus piperacillin/tazobactam for diabetic foot infections in China: a Phase 3, multicentre, randomized, double-blind, active-controlled, non-inferiority trial. AU - Xu,Zhang-Rong, AU - Ran,Xing-Wu, AU - Xian,Yang, AU - Yan,Xiao-Dong, AU - Yuan,Guo-Yue, AU - Mu,Sheng-Mei, AU - Shen,Ju-Fang, AU - Zhang,Bo-Shao, AU - Gan,Wei-Jin, AU - Wang,Jue, Y1 - 2016/02/16/ PY - 2015/06/24/received PY - 2016/01/04/accepted PY - 2016/2/19/entrez PY - 2016/2/19/pubmed PY - 2017/2/24/medline SP - 1688 EP - 96 JF - The Journal of antimicrobial chemotherapy JO - J Antimicrob Chemother VL - 71 IS - 6 N2 - OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1460-2091 UR - https://www.unboundmedicine.com/medline/citation/26888908/Ertapenem_versus_piperacillin/tazobactam_for_diabetic_foot_infections_in_China:_a_Phase_3_multicentre_randomized_double_blind_active_controlled_non_inferiority_trial_ L2 - https://academic.oup.com/jac/article-lookup/doi/10.1093/jac/dkw004 DB - PRIME DP - Unbound Medicine ER -