Efficacy and Safety of Tedizolid Phosphate versus Linezolid in a Randomized Phase 3 Trial in Patients with Acute Bacterial Skin and Skin Structure Infection

作者：Xiaoju Lv, Jeff Alder, Li Li, William O’Riordan, Michael J. Rybak, Hui Ye, Ruiping Zhang, Zhongqi Zhang, Xu Zhu, Mark H. Wilcox · 发表于：Antimicrobial Agents and Chemotherapy · 年份：2019 · DOI：10.1128/aac.02252-18 · 被引用次数：48 · 研究领域：Antimicrobial Resistance in Staphylococcus、Bacterial Identification and Susceptibility Testing、Streptococcal Infections and Treatments

= 1; modified ITT), comparable early response rates were observed (tedizolid, 77.4%; linezolid, 80.1%; treatment difference, -2.7%; 95% CI, -9.4, 3.9). Secondary endpoints showed high and similar clinical success rates in the ITT and clinically evaluable (CE) populations at EOT and PTE visits (e.g., CE-PTE for tedizolid, 90.4%; for linezolid, 93.5%). Both drugs were well tolerated, and no death occurred. Eight patients experienced phlebitis with tedizolid while none did with linezolid; hence, drug-related treatment-emergent adverse events were reported in a slightly higher proportion in the tedizolid (20.9%) arm than in the linezolid arm (15.8%). The study demonstrated that tedizolid in a primarily Asian population was an efficacious and well-tolerated treatment option for ABSSSI patients. (This study has been registered at ClinicalTrials.gov under registration no. NCT02066402.).