Comparison of Efficacy and Safety Profiles Between Omadacycline and Moxifloxacin in Elderly Patients with Community‐Acquired Pneumonia: A Randomized, Controlled Trial

莫西沙星 医学 临床终点 随机对照试验 内科学 细菌性肺炎 临床疗效 临床试验 不利影响 肺炎 抗生素 泌尿科 麻醉 药效学 外科 随机化 安全概况
作者
Muming Yu,Xiaorong Wang,Sitong Wu,Zikang Zhou,Yancun Liu,Yan-fen Chai
出处
期刊:Clinical pharmacology in drug development [Wiley]
标识
DOI:10.1002/cpdd.1627
摘要

Abstract Omadacycline is a novel aminomethylcycline antibiotic that shows non‐inferior efficacy to moxifloxacin in adults with community‐acquired pneumonia (CAP), but lacking clinical evidence in elderly patients with CAP. This randomized, controlled study aimed to investigate the efficacy and safety of omadacycline in elderly patients with CAP. Eligible elderly patients with CAP were randomized at a 1:1 ratio to the omadacycline group (n = 48) and moxifloxacin group (n = 49) to receive the corresponding agent. The primary endpoint was clinical response. The most common pathogens in the omadacycline and moxifloxacin groups were viridans streptococci (16.7%, 16.3%), Klebsiella pneumoniae (14.6%, 14.3%), and Neisseria sicca (14.6%, 14.3%). Clinical response rate was greater in the omadacycline group compared to the moxifloxacin group (54.2% vs 26.5%, P = .032). The omadacycline group showed higher significant improvement rate (41.7% vs 16.3%, P = .02), but similar complete recovery (12.5% vs 10.2%, P = .737), effective improvement (37.5% vs 59.2%, P = .125), and ineffectiveness (8.3% vs 14.3%, P = .384) rates compared to the moxifloxacin group. Results of C‐reactive protein, procalcitonin, and interleukin‐6 at baseline and after treatment, as well as their changes did not vary between the omadacycline and moxifloxacin groups (all P > .05). No difference was observed in liver, kidney, and coagulation function parameters between the two groups (all P > .05). Omadacycline indicates greater treatment efficacy and comparable safety profiles versus moxifloxacin in elderly patients with CAP.
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