A Double-blind, Randomized Trial of Moxifloxacin and Placebo for Six Months vs

结核病仍然是全球主要的传染病杀手，新增病例900万例，死亡200万例。 根据世界卫生组织的数据，每年。对结核病药物的抗药性在 过去15年，耐多药结核病的死亡率(MDR IB-定义为对 一线药物异烟肼(INH)和利福平(RIF)在艾滋病毒感染者和未感染者中都很高。 在接触过耐多药结核病的人中预防疾病发展是最有效的 阻止向未感染者传播的方法，然而，潜伏结核病感染的传统治疗方法是 INH，目前推荐的耐多药结核病LTBI的治疗方案是氧氟沙星，一种相对 抗结核分枝杆菌活性较弱。预防疾病发展的新方法 接触耐多药结核病的人是至关重要的。该项目是两种治疗潜伏期方案的随机试验 耐多药肺结核患者接触者的结核感染情况。我们将随机选择220名患者接受莫西沙星治疗 (莫昔洛韦)单用6个月与氧氟沙星/埃米巴治疗6个月，结果是安全性、耐受性和 有效性。我们假设，仅Moxi一个人就会有很少的不良事件，更高的完成率，以及 与氧氟沙星/EMB的疗效相似。管理和生物统计/数据管理核心将支持这一点 学习。这些试验将有助于提高我们对全球结核病控制的了解。

Tuberculosis remains a major infectious disease killer globally, with 9 million new cases and 2 million deaths annually according to the World Health Organization. Resistance to tuberculosis drugs has increased in the last 15 years, and mortality rates from multidrug resistant tuberculosis (MDR IB-defined as resistance to both first line drugs Isoniazid (INH) and rifampin (RIF)) are high in both HIV infected and uninfected persons. Preventing the development of disease in people who have been exposed to MDR TB is the most efficient way to halt transmission to uninfected persons, however traditional treatment for latent TB infection is with INH, and current recommended treatment for MDR TB LTBI is with oflaxacin, a quinalone with relatively weak activity against Mycobacterium tuberculosis. New methods of preventing development of disease in people exposed to MDR TB are vital. This project is a randomized trial of two treatment regimens for latent TB infection of contacts of patients with MDR TB. We will randomize 220 patients to receive moxifloxacin (moxi) alone for 6 months vs. ofloxacin/EMB for 6 months, with outcomes of safety, tolerablility and effectiveness. We hypothesize that moxi alone will have few adverse events, higher completions rates, and similar efficacy vs. ofloxacin/EMB. Administrative and biostats/data management cores will support this study. These trials will contribute to improving our understanding of the control of TB worldwide.