Cempra Pharmaceuticals, Chapel Hill, North Carolina, USA.
Clin Infect Dis. 2011 Jun;52 Suppl 7:S520-6. doi: 10.1093/cid/cir167.
Fusidic acid (CEM-102), an orally bioavailable fusidane antibiotic with a unique mode of action, is under development for treatment of acute gram-positive bacterial skin and skin structure infections, including those caused by methicillin-susceptible and methicillin-resistant Staphylococcus aureus and streptococci. A phase 2, adaptive design, randomized, double-blind, multiple-center study of 198 adult patients with cellulitis or wound infections was conducted to evaluate an oral CEM-102 loading-dose regimen (1500 mg twice per day on day 1 followed by 600 mg twice per day) compared with oral linezolid (600 mg twice per day) administered for 10-14 days. The CEM-102 loading-dose regimen demonstrated efficacy, safety, and tolerability that was comparable to linezolid for the treatment of acute gram-positive bacterial skin and skin structure infections. Clinical Trials registration. NCT00948142.
夫西地酸（CEM-102）是一种具有独特作用机制的可口服应用的夫地烷类抗生素，目前正在开发用于治疗急性革兰阳性细菌皮肤和皮肤结构感染，包括由甲氧西林敏感和甲氧西林耐药金黄色葡萄球菌和链球菌引起的感染。一项评估口服 CEM-102 负荷剂量方案（第 1 天每天 2 次给予 1500mg，然后每天 2 次给予 600mg）与口服利奈唑胺（每天 2 次给予 600mg）治疗 10-14 天的疗效、安全性和耐受性的 2 期适应性设计、随机、双盲、多中心研究纳入了 198 例患有蜂窝织炎或伤口感染的成年患者。CEM-102 负荷剂量方案在治疗急性革兰阳性细菌皮肤和皮肤结构感染方面的疗效、安全性和耐受性与利奈唑胺相当。临床试验注册。NCT00948142。
