Effectiveness of Azithromycin in Eradicating Nasopharyngeal Carriage of N. Meningitidis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 764
- 试验地点
- 2
- 主要终点
- Eradication of N. meningitidis carriage
研究概览
简要总结
The purpose of this study is to determine the effectiveness of azithromycin in the eradication of nasopharyngeal carriage of N. meningitidis
详细描述
Azithromycin belongs to the class of antimicrobials known as macrolides. They are approved for the treatment of a wide variety of infections, including community-acquired respiratory tract infections and sexually transmitted infections caused by different bacteria. Their mechanism of action is dependent on bacterial ribosomal binding, leading to inhibition of bacterial protein synthesis. Azithromycin has a broad spectrum of activity to include Gram-positive and Gram-negative organisms, as well as atypical and mycobacterial organisms.
A single oral dose of 500mg of azithromycin has been shown to eradicate N. meningitidis colonization. Historically, azithromycin has not been recommended as first-line chemoprophylaxis for close contacts of patients with invasive meningococcal disease (IMD) since it has not been well studied for this indication. A study from 2020 evaluated the activity of azithromycin against 205 invasive N. meningitidis isolates and found that 100% were susceptible according to Clinical and Laboratory Standards Institute (CLSI) breakpoints. Moreover, with the rise in cases of meningococcal disease caused by ciprofloxacin-resistant strains, the Centers for Disease Control and Prevention (CDC) recently updated their guidance to health department for when to consider other options (including azithromycin).
Participants identified as carriers of N. meningitidis will be asked to take a one-time oral dose of azithromycin, 500mg (standard dose).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide their own informed consent and understand study procedures
- •Undergraduate and graduate students attending Emory University affiliated campuses who reside in university affiliated housing (for undergraduate/graduate) or in off-campus housing (undergraduates).
排除标准
- •University faculty and staff
- •Currently pregnant or breast feeding
- •History of immediate or moderate-to-severe allergic reactions to azithromycin
- •Individuals who have taken systemic antibiotics for any reason in the 30 days prior to enrollment
- •Individuals with any symptoms of acute illness at the time of screening
研究组 & 干预措施
Azithromycin
Persons with microbiologic documentation of N. meningitidis carriage will receive a single, standard dose of azithromycin.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Eradication of N. meningitidis carriage
时间窗: Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration)
Eradication of N. meningitidis carriage is defined as positive culture at the second visit (immediately prior to azithromycin administration) and negative culture approximately 2 weeks after antibiotic administration.
次要结局
- Proportion of Participants Culture-Positive(Day 1 (screening visit))
- Risk Factors for Meningococcal Carriage(Day 1 (screening visit))
- Proportion of Participants Culture-Positive(Day 1 (screening visit))
- Minimal Inhibitory Concentrations (MICs) for Ciprofloxacin(Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration))
- Minimal Inhibitory Concentrations (MICs) for Rifampin(Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration))
- Minimal Inhibitory Concentrations (MICs) for Ceftriaxone(Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration))
- Minimal Inhibitory Concentrations (MICs) for Azithromycin(Day 7 (immediately prior to azithromycin administration), Day 21 (2 weeks after azithromycin administration))
- Risk Factors for Meningococcal Carriage(Day 1 (screening visit))
研究者
Paulina Rebolledo
Associate Professor
Emory University