From the Merck Research Laboratories, Rady Children's Hospital/UCSD, San Diego, CA.
Merck Research Laboratories, LTD M. Iashvili Children's Central Hospital, Tbilisi, Georgia.
Pediatr Infect Dis J. 2021 Mar 1;40(3):238-244. doi: 10.1097/INF.0000000000003010.
Tedizolid phosphate is an oxazolidinone prodrug approved in 2014 for treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs); however, efficacy has not previously been evaluated in children. This study compared the safety and efficacy of tedizolid (administered as tedizolid phosphate) with active antibacterial comparators for the treatment of ABSSSIs in adolescents.
This was a randomized, assessor-blind, global phase 3 study of tedizolid versus active comparators for the treatment of Gram-positive ABSSSIs in adolescents (12 to <18 years of age; NCT02276482). Enrolled participants were stratified by region and randomized 3:1 to receive tedizolid phosphate 200 mg (oral and/or intravenous) once daily for 6 days or active comparator, selected by investigator from an allowed list per local standard of care, for 10 days. The primary endpoint was safety; blinded investigator's assessment of clinical success at the test-of-cure visit (18-25 days after the first dose) was a secondary efficacy endpoint. Statistical comparisons between treatment groups were not performed.
Of the 121 participants enrolled, 120 were treated (tedizolid, n = 91; comparator, n = 29). Treatment-emergent adverse events were balanced between treatment groups (tedizolid, 14.3%; comparator, 10.3%). Overall, 3 participants (3.3%) in the tedizolid group and 1 (3.4%) in the comparator group experienced a single drug-related TEAE. Clinical success rates were high in both treatment groups: 96.7% and 93.1% at the test-of-cure visit for the tedizolid and comparator groups, respectively.
Tedizolid demonstrated safety and efficacy similar to comparators for the treatment of ABSSSIs in adolescents.
替加环素磷酸盐是一种噁唑烷酮类前药，于 2014 年获批用于治疗成人急性细菌性皮肤和皮肤结构感染（ABSSSIs）；然而，此前尚未在儿童中评估其疗效。本研究比较了替加环素（作为替加环素磷酸盐给药）与活性抗菌对照药物治疗青少年 ABSSSIs 的安全性和疗效。
这是一项在全球范围内进行的、随机、评估者盲法的 3 期研究，比较了替加环素与活性对照药物治疗青少年（12 至<18 岁；NCT02276482）革兰阳性 ABSSSIs 的疗效。入组患者按地区分层，按 3:1 的比例随机分组，分别接受替加环素磷酸盐 200mg（口服和/或静脉注射），每日 1 次，连用 6 天，或研究者根据当地标准护理的允许清单选择活性对照药物，连用 10 天。主要终点为安全性；治疗结束时（首次给药后 18-25 天）盲法评估临床疗效为次要疗效终点。未对治疗组间进行统计学比较。
在 121 名入组患者中，120 名患者接受了治疗（替加环素组，n=91；对照组，n=29）。治疗期间不良事件在两组间均衡（替加环素组，14.3%；对照组，10.3%）。替加环素组和对照组各有 3 名（3.3%）和 1 名（3.4%）患者发生 1 例药物相关的治疗期间不良事件。两组的临床治愈率均较高：替加环素组和对照组在治疗结束时的临床治愈率分别为 96.7%和 93.1%。
替加环素治疗青少年 ABSSSIs 的安全性和疗效与对照药物相似。
