Dataset from Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Efficacy of Retapamulin Ointment, 1% Applied Twice Daily for 3 or 5 Days to the Anterior Nares of Healthy Adult Subjects Nasally Colonized With Staphylococcus Aureus

This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3 or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S. aureus. Approximately 57 healthy subjects who are nasal carriers of S. aureus will be enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19 intermittent carriers complete the study. Each eligible subject will participate in three screening visits, a treatment period, and two follow-up visits. Each subject's participation in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit. Subjects will participate in up to three screening visits to determine S. aureus culture positivity and colonization status.

本研究为一项I/IIa期随机双盲安慰剂对照临床试验，旨在评估1%瑞他莫林软膏（Retapamulin ointment）每日两次、连续3或5天涂抹于前鼻腔，对鼻内定植金黄色葡萄球菌（Staphylococcus aureus，简称S. aureus）的健康成年受试者的安全性、耐受性、药代动力学（Pharmacokinetics，简称PK）与疗效。本研究计划入组约57名金黄色葡萄球菌鼻腔携带者健康受试者，按照2:1的比例进行分层随机分组，以确保至少38名持续定植者与19名间歇定植者完成全部研究流程。每名符合入组标准的受试者将参与3次筛选访视、1个治疗阶段以及2次随访访视。每名受试者从筛选启动至最后一次随访访视的总研究周期约为6至10周。受试者需完成最多3次筛选访视，以确认金黄色葡萄球菌培养阳性结果及定植状态。