Efficacy and safety of eravacycline versus ertapenem in the treatment of complicated intraperitoneal infection in Chinese adults:a multicenter,randomized,double-blind phase Ⅲ bridging trial
10.16718/j.1009-7708.2024.03.001
- VernacularTitle:依拉环素与厄他培南对比治疗中国成人复杂性腹腔感染的疗效和安全性
- Author:
Xiaoju LÜ
1
;
Gang CHEN
;
Shuanghai LIU
;
Xiaorong LI
;
Zhongtao ZHANG
Author Information
1. 四川大学华西医院感染性疾病中心,成都 610041
- Keywords:
complicated intra-abdominal infection;
eravacycline;
ertapenem;
phase Ⅲ clinical trial
- From:
Chinese Journal of Infection and Chemotherapy
2024;24(3):249-256
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of eravacycline in the treatment of complicated intra-abdominal infection(cIAI)in Chinese adult patients.Methods In this multicenter,randomized,double-blind phase Ⅲ study,cIAI patients were randomly assigned to receive either eravacycline(1.0 mg/kg,q12h)or ertapenem(1 g,q24h)by intravenous infusion for 5 to 14 days.The primary and secondary efficacy endpoints included the clinical efficacy and microbiological efficacy in different populations,including modified intention-to-treat(MITT)population,clinically evaluable(CE)population,and microbiologically evaluable(ME)population,at different time points after treatment.Clinical cure rates at specific visits were summarized and compared between treatment groups in different populations.The microbial eradication rate was calculated for the patients with baseline pathogens.The incidence of adverse events(AE)and drug-related treatment emergent adverse event(TEAE)was analyzed by treatment group.Results A total of 144 patients with cIAI who received at least one dose of the study drug were included in the MITT population.The clinical cure rate was 77.8％(56/72)in eravacycline-treated patients and 90.3％(65/72)in ertapenem-treated patients at 25-31 days after the first dose(TOC visit).When the patients who received insufficient treatment(＜72 hours)were excluded,the clinical cure rate was 83.6％(56/67)in eravacycline group and 90.3％(65/72)in ertapenem.For CE and ME patients,the clinical cure rate at TOC visit was 91.1％(51/56)and 83.3％(25/30)in eravacycline group,95.3％(61/64)and 90.9％(30/33)in ertapenem group.Eravacycline treatment achieved microbiological eradication rate of 91.3％(21/23)against Escherichia coli at TOC visit in micro-MITT population while ertapenem treatment resulted in a microbiological eradication rate of 96.2％(25/26).The microbiological efficacy of eravacycline and ertapenem against Klebsiella pneumoniae was 4/5 and 3/3,respectively.The incidence of TEAE was similar in eravacycline and ertapenem groups(75.0％vs.70.8％),most of which were mild or moderate.The AEs associated with eravacycline were mainly infusion site phlebitis(9.7％,7/72)and infusion site pain(8.3％,6/72).Conclusions Similar to ertapenem,eravacycline has good clinical and microbiological efficacy in treating cIAI.It is also safe and well-tolerated in the patients.
