Efficacy and safety of amoxicillin-clavulanate(10∶1)for injection versus ampicillin-sulbactam in the treatment of community-acquired pneumonia
10.16718/j.1009-7708.2025.04.001
- VernacularTitle:注射用阿莫西林-克拉维酸(10∶1)与氨苄西林-舒巴坦对比治疗社区获得性肺炎的疗效和安全性
- Author:
Xiaohua QIN
1
;
Haihui HUANG
;
Xingang HUANG
;
Shenghua SUN
;
Dongyang HE
;
Wenjing WANG
;
Yingyuan ZHANG
Author Information
1. 复旦大学附属华山医院抗生素研究所,国家卫健委抗生素临床药理重点实验室,上海 200040
- Publication Type:Journal Article
- Keywords:
community-acquired pneumonia;
amoxicillin-clavulanate;
multi-center;
non-inferiority;
double-blind;
randomized controlled trial;
efficacy;
safety
- From:
Chinese Journal of Infection and Chemotherapy
2025;25(4):357-363
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of amoxicillin-clavulanate(10∶1)for injection in the treatment of community-acquired pneumonia(CAP)in adult patients.Methods Eligible patients were randomized to receive amoxicillin-clavulanate(10∶1)2.2 g or ampicillin-sulbactam(2∶1)3.0 g via intravenous infusion q12h or q8h for 7 to 14 days.The primary endpoint was to the clinical efficacy 7-14 days after discontinuation of treatment.The secondary endpoints included microbiological efficacy and safety.Results All enrolled patients(n=324)were included in the full analysis set(FAS),specifically 165 patients receiving amoxicillin sodium-clavulanate potassium(10∶1)and 159 patients receiving ampicillin sodium-sulbactam sodium(2∶1).The clinical cure rate was 78.8％(130/165)for amoxicillin-clavulanate(10∶1)and 77.4％(123/159)for ampicillin-sulbactam 7-14 days after end of treatment(P＞0.05).The clinical cure rate was 87.5％(126/144)for amoxicillin-clavulanate(10∶1)and 87.4％(111/127)for ampicillin-sulbactam(2∶1)in per protocol set(P＞0.05).Therefore,amoxicillin-clavulanate(10∶1)was non-inferior to ampicillin-sulbactam in the primary endpoint in the treatment of CAP in adult patients.The overall bacterial eradication rate was 94.4％(34/36)for amoxicillin-clavulanate(10∶1)and 89.3％(25/28)for ampicillin-sulbactam(P＞0.05).The common study drug-related clinical adverse event were abnormalities of hepatic function in both the amoxicillin-clavulanate(10∶1)group(4.8％,8/165)and ampicillin-sulbactam group(3.1％,5/159)(P＞0.05).Conclusions Amoxicillin-clavulanate(10∶1)2.2 g Ⅳ infusion q12h or q8h for 7-14 days was noninferior to ampicillin-sulbactam in terms of clinical and microbiological efficacy in the treatment of CAP in adult patients.The safety of the two dosing regimens was comparable.
