[Translation] A study of intravenous aztreonam-avibactam with or without combination in pediatric subjects 9 months to less than 18 years of age with severe Gram-negative infections, including complicated intra-abdominal infections Phase IIa, multicenter, observer-blinded, randomized two-arm study of the pharmacokinetics, safety, tolerability, and efficacy of metronidazole compared with best available treatment (BAT)
该研究拟使用的生物样本来自于确诊为严重革兰阴性菌感染的受试者。本研究的研究目的为在 9 月龄至<18 岁受试者中评估 ATM-AVI用于治疗严重革兰阴性菌感染的 PK 和在 9 月至<18岁受试者中评估 ATM-AVI 和BAT用于治疗严重革兰阴性菌感染的安全性和耐受性及疗效,拟使用全血、血清等人类遗传资源进行分析和检测。
[Translation] The biological samples to be used in this study come from subjects diagnosed with severe Gram-negative bacterial infections. The purpose of this study was to evaluate the PK of ATM-AVI for the treatment of serious gram-negative bacterial infections in subjects 9 months to <18 years of age and to evaluate the efficacy and safety of ATM-AVI in subjects 9 months to <18 years of age. The safety, tolerability and efficacy of BAT in treating severe gram-negative bacterial infections are planned to be analyzed and tested using human genetic resources such as whole blood and serum.