Abstract Number:

36-LB

Title:

Ertapenem for Diabetic Foot Infections in China: A Multicentre, Randomised, Double-Blinded, Active-Controlled Study（厄他培南治疗中国糖尿病足患者的多中心、随机、双盲、阳性药物对照研究）

Authors:

ZR XU, XW RAN, YANG XIAN, XD YAN, GY YUAN, SM MU, JF SHEN, BS ZHANG, WJ GAN, JUE WANG, MK0826-061 DFI STUDY GROUP, Beijing, China, Chengdu, China, Nanning, China, Zhenjiang, China, Shanghai,China

Abstract:

Diabetic foot infections (DFIs) are common and serious complications affecting worldwide diabetes population. Few randomised studies have assessed antibiotic regimens in Asian populations. Our objective was to assess the efficacy and safety of ertapenem versus piperacillin/tazobactam (TZP) for DFIs in Chinese population.
Diabetic adults (n=565) with moderate-to-severe DFIs requiring intravenous (IV) antibiotics were randomly assigned either ertapenem (1g daily) or TZP (4.5g every 8h) for a minimum of 5 days. Oral amoxicillin/clavulanate (625mg every 12h) could be given for 23 days at maximum after IV therapy. Vancomycin may be allowed for bacterial species known resistant (i.e. Enterococcus spp) to study therapy. The primary outcome was the proportion of patients with a favourable clinical response on the day that IV antibiotic was discontinued (DCIV). An evaluable-patient population was identified for primary analysis. Safety was assessed across the study.
At DCIV, 443 patients were assessed clinically evaluable and 533 MITT qualified. Baseline characteristics between groups were comparable. Findings on primary outcome were summarised in table.
Safety was similar by ertapenem versus TZP based on drug-related AE (13.5% vs. 16.0%) and AE leading to discontinuation (4.0% vs. 5.8%).
Ertapenem is non-inferior to piperacillin/tazobactam and may be an option for DFIs in China.