PDF(Pubmed)
Abstract：
Ceftibuten/ARX-1796 (avibactam prodrug) is a novel oral antibacterial combination in early clinical development for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis. ARX-1796 is the novel avibactam prodrug being combined with ceftibuten for oral dosing that is converted to active avibactam in vivo. A Clinical and Laboratory Standards Institute (CLSI) M23 (2018) tier 2 broth microdilution quality control (QC) study was conducted with ceftibuten-avibactam to establish MIC QC ranges. Ceftibuten-avibactam broth microdilution QC ranges were approved for Escherichia coli ATCC 25922 (0.016/4 to 0.12/4 μg/mL), E. coli NCTC 13353 (0.03/4 to 0.12/4 μg/mL), Klebsiella pneumoniae ATCC 700603 (0.06/4 to 0.25/4 μg/mL), K. pneumoniae ATCC BAA-1705 (0.03/4 to 0.25/4 μg/mL), and K. pneumoniae ATCC BAA-2814 (0.12/4 to 0.5/4 μg/mL) by the CLSI Subcommittee on Antimicrobial Susceptibility Testing in January 2022. Approved ceftibuten-avibactam QC ranges will support future clinical development, device manufacturers, and routine patient care.
摘要：
头孢替丁/ARX-1796（阿维巴坦前药）是一种新型的口服抗菌组合，用于早期临床开发，用于治疗包括肾盂肾炎在内的复杂尿路感染（cUTI）。ARX-1796是与头孢替丁组合用于口服给药的新型阿维巴坦前药,其在体内转化为活性阿维巴坦。临床和实验室标准研究所（CLSI）M23（2018）第2级肉汤微量稀释质量控制（QC）研究使用头孢替布汀-阿维巴坦进行，以建立MICQC范围。头孢替丁-阿维巴坦肉汤微量稀释QC范围被批准用于大肠杆菌ATCC25922（0.016/4至0.12/4μg/mL），大肠杆菌NCTC13353（0.03/4至0.12/4μg/mL），肺炎克雷伯菌ATCC700603（0.06/4至0.25/4μg/mL），肺炎克雷伯菌ATCCBAA-1705（0.03/4至0.25/4μg/mL），和肺炎克雷伯菌ATCCBAA-2814（0.12/4至0.5/4μg/mL）由CLSI抗菌药物敏感性测试小组委员会于2022年1月进行。批准的头孢替丁-阿维巴坦QC范围将支持未来的临床发展，设备制造商，和常规病人护理。
