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

相对较长的标准结核病(TB)疗程仍然是影响 疾病治愈率以及提供直接观察治疗的行政负担。新药 因此，需要采用治疗方案来缩短结核病的治疗时间。氟喹诺酮类药物莫西沙星 抗生素，对大多数结核分枝杆菌菌株有效，最近的实验和临床数据 提示莫西沙星可能是一种有效的消毒剂，可缩短活动性肺炎的治疗时间。 结核病。这项II/III期临床试验的主要目标是比较实验四种药物的活性。 以莫西沙星为基础的1个月治疗方案改为常规的6个月治疗方案 活动性肺结核。我们假设莫西沙星方案的耐受性会更好，有更高的 完成率，并将在治愈疾病方面毫不逊色。这将是一个单中心，随机的，双人的 盲法临床试验。受试者将是呼吸道涂片阳性的HIV血清阴性者，培养确认 从弗拉加大学医院结核病诊所招募的肺结核患者 巴西里约热内卢的菲尔霍。我们将随机选择526名患者接受 莫西沙星/利福平/吡津酰胺/乙胺丁醇治疗4个月与对照方案 异烟肼/利福平/吡津酰胺/乙胺丁醇，疗程6个月。每种疗法的疗效将会被确定。 通过比较治疗后两年的复发率和治疗失败率。这 这项研究将有助于理解莫西沙星作为结核病治疗缩短剂的用途。

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.