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Clinical pharmacology in drug development · 2025

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

СтатьяРандомизированное исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Yu Muming, Wang Xiaorong, Wu Sitong, Zhou Zikang, Liu Yancun, Chai Yanfen

Аннотация

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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