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

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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.