A Randomized Trial of a Four Month Moxifloxacin-based Regimen for Treatment of

标准结核病（TB）治疗的相对漫长的过程仍然是一个主要问题， 疾病治愈率以及提供直接观察治疗的行政负担。新药 因此需要治疗方案来缩短结核病治疗。莫西沙星，一种氟喹诺酮 抗生素，对大多数M.结核病，以及最近的实验和临床数据 表明，阿托沙星可能是一种有效的杀菌剂，可以缩短治疗活性的持续时间， TB.这项II / III期临床试验的主要目的是比较实验性四种药物的活性， 与常规6个月治疗方案相比， 活动性肺结核我们假设，利多卡因方案将更好地耐受，将有更高的 完成率，并将在治疗疾病的非劣。这将是一项单中心、随机、双 盲法临床试验受试者将是HIV血清阴性、呼吸道涂片阳性、培养证实的个体 从克莱门蒂诺弗拉加大学医院结核病诊所招募的肺结核患者 里约热内卢，巴西的距离我们将随机抽取526名患者， 利福沙星/利福平/吡嗪酰胺/乙胺丁醇治疗4个月，对照方案为 异烟肼/利福平/吡嗪酰胺/乙胺丁醇6个月。将确定每种方案的疗效 通过比较治疗后两年的复发率和治疗失败率。这 这项研究将有助于了解利福沙星作为结核病治疗缩短剂的效用。

The relatively lengthy course of standard tuberculosis (TB) treatment remains a major problem that impacts disease cure rates as well as the administrative burden of providing directly-observed therapy. New drugs and treatment regimens are therefore needed to shorten TB treatment. Moxifloxacin, a fluoroquinolone antibiotic, is active against most strains of M. tuberculosis, and recent experimental and clinical data suggests that moxifloxacin may be a potent sterilizing agent that could shorten duration of treatment of active TB. The primary objective of this Phase II / III clinical trial is to compare the activity of an experimental four month moxifloxacin-based treatment regimen to a conventional six month treatment regimen in patients with active pulmonary TB. We hypothesize that the moxifloxacin regimen will be better tolerated, will have higher completion rates, and will be non-inferior in curing disease. This will be a single center, randomized, double blind clinical trial. Subjects will be HIV-seronegative individuals with respiratory smear positive, cultureconfirmed pulmonary TB who are recruited from the TB clinic at Hospital Universitario Clementino Fraga Filho in Rio de Janeiro, Brazil. We will randomize 526 patients to receive moxifloxacin/rifampin/pyrazinamide/ethambutol for 4 months versus a control regimen of isoniazid/rifampin/pyrazinamide/ethambutol for 6 months. The efficacy of each regimen will be determined by comparing the relapse rates over a two-year post treatment period and the treatment failure rates. This study will contribute to the understanding of the utility of moxifloxacin as a TB treatment shortening agent.