A Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy of Retapamulin as a Topical Decolonizing Agent for Mupirocin Resistant Methicillin Resistant Staphylococcus Aureus (MRSA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo
研究概览
简要总结
The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The sample size will include 27 subjects in each of the two arms of the study (retapamulin versus placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal colonized with MRSA will be randomized to receive either retapamulin or placebo applied nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at pre-defined time points during study duration (screening swab, swab one week after completion of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA colonization status. The colonization rates of both groups will be assessed via Fisher's Exact Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to the general pediatric floor and pediatric intensive care units at NYU Langone Medical Center or visit to study team members at ODA clinic (Park Ave locations) in Williamsburg Brooklyn.
- •Ages 9 months to 17 years
- •Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a current outbreak of this strain of MRSA.
- •Nasal and/or rectal culture positive for mupirocin-resistant methicillin-resistant Staphylococcus aureus (MRSA)
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Pregnant or lactating
- •Unable to appropriately consent
- •Open sores in either of the study sites (nares or rectum)
- •Recent surgical procedure to either study site (nares or rectum)
- •Concurrent use of Rifampin or Trimethoprim/Sulfamethoxazole
- •Current active MRSA infection
- •Immunocompromised
- •Presence of endotracheal tube, tracheostomy tube or other foreign body in upper airway
研究组 & 干预措施
Retapamulin
Thin layer of ointment applied twice a day for five days. Study drug will be applied to the nares and peri-rectal area twice a day for 5 consecutive days.
干预措施: Retapamulin (Drug)
Placebo
The placebo used will be a triple purified pharmaceutical grade white petrolatum
干预措施: Placebo Ointment (Drug)
结局指标
主要结局
Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo
时间窗: 1 Week
Study visit for nasal/peri-rectal swabs
Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo
时间窗: 4 Weeks
Study visit for nasal/peri-rectal swabs
次要结局
未报告次要终点