TAILIEUCHUNG - Delamanid for Multidrug-Resistant Pulmonary Tuberculosis

In this randomized, placebo-controlled, multinational clinical trial, we assigned 481 patients (nearly all of whom were negative for the human immunodeficiency virus) with pulmonary multidrug-resistant tuberculosis to receive delamanid, at a dose of 100 mg twice daily (161 patients) or 200 mg twice daily (160 patients), or placebo (160 patients) for 2 months in combination with a background drug regimen developed according to World Health Organization guidelines. Sputum cultures were assessed weekly with the use of both liquid broth and solid medium; sputum-culture conversion was defined as a series of five or more consecutive cultures that were negative for growth of M. tuberculosis. The primary efficacy end point. | The new ENGLAND JOURNAL of MEDICINE ESTABLISHED IN 1812 JUNE 7 2012 VOL. 366 NO. 23 Delamanid for Multidrug-Resistant Pulmonary Tuberculosis Maria Tarcela Gler . Vija Skripconoka . Epifanio Sanchez-Garavito . Heping Xiao . Jose L. Cabrera-Rivero . Dante E. Vargas-Vasquez . Mengqiu Gao . . Mohamed Awad . . . Seung-Kyu Park . . Tae Sun Shim . . Gee Young Suh . Manfred Danilovits . Hideo Ogata . Anu Kurve . Joon Chang . . Katsuhiro Suzuki . Thelma Tupasi . Won-Jung Koh . Barbara Seaworth . Lawrence J. Geiter . and Charles D. Wells . abstract background Delamanid OPC-67683 a nitro-dihydro-imidazooxazole derivative is a new antituberculosis medication that inhibits mycolic acid synthesis and has shown potent in vitro and in vivo activity against drug-resistant strains of Mycobacterium tuberculosis. methods In this randomized placebo-controlled multinational clinical trial we assigned 481 patients nearly all of whom were negative for the human immunodeficiency virus with pulmonary multidrug-resistant tuberculosis to receive delamanid at a dose of 100 mg twice daily 161 patients or 200 mg twice daily 160 patients or placebo 160 patients for 2 months in combination with a background drug regimen developed according to World Health Organization guidelines. Sputum cultures were assessed weekly with the use of both liquid broth and solid medium sputum-culture conversion was defined as a series of five or more consecutive cultures that were negative for growth of M. tuberculosis. The primary efficacy end point was the proportion of patients with sputum-culture conversion in liquid broth medium at 2 months. results Among patients who received a background drug regimen plus 100 mg of delama-nid twice daily had sputum-culture conversion in liquid broth at 2 months as compared with of patients who received a background drug regimen plus placebo P . Likewise as compared with the .

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