Substitution of Rifapentine for Rifampin During Intensive Phase Treatment of Pulmonary Tuberculosis: Study 29 of the Tuberculosis Trials Consortium
Por:
Dorman, SE, Goldberg, S, Stout, JE, Muzanyi, G, Johnson, JL, Weiner, M, Bozeman, L, Heilig, CM, Feng, PJ, Moro, R, Narita, M, Nahid, P, Ray, S, Bates, E, Haile, B, Nuermberger, EL, Vernon, A, Schluger, NW, Sambeat, MA, TB Trials Consortium
Publicada:
1 oct 2012
Resumen:
Methods. In total, 531 adults with sputum smear-positive pulmonary tuberculosis were randomized to rifapentine 10 mg/kg/dose or rifampin 10 mg/kg/dose, administered 5 days per week for 8 weeks (intensive phase), with isoniazid, pyrazinamide, and ethambutol. Coprimary outcomes were negative sputum culture on liquid and on solid media at completion of intensive phase.
Results. Negative cultures on solid media occurred in 145 of 174 participants (83.3%) in the rifampin group and 171 of 198 participants (86.4%) in the rifapentine group (difference, 3.0%; 95% confidence interval [CI]: - 4.3, 10.5); negative cultures in liquid media occurred in 110 of 169 (65.1%) in the rifampin group and 133 of 196 (67.9%) in the rifapentine group (difference, 2.8%; 95% CI: -6.9, 12.4). Among 529 participants who received study therapy, 40 of 254 participants (15.7%) in the rifampin group and 40 of 275 participants (14.5%) in the rifapentine group prematurely discontinued treatment (P = .79).
Conclusions. The rifapentine regimen was safe but not significantly more active than a standard rifampin regimen, by the surrogate endpoint of culture status at completion of intensive phase. Assessment of higher exposures to rifapentine for tuberculosis treatment is warranted.
Clinical Trials registration. NCT00694629.
Filiaciones:
Dorman, SE:
Johns Hopkins Univ, Ctr TB Res, Sch Med, Baltimore, MD 21231 USA
Goldberg, S:
Ctr Dis Control & Prevent, Atlanta, GA USA
Stout, JE:
Duke Univ, Sch Med, Durham, NC USA
Muzanyi, G:
Uganda Case Western Reserve Univ Res Collaborat, Kampala, Uganda
Johnson, JL:
Uganda Case Western Reserve Univ Res Collaborat, Kampala, Uganda
Case Western Reserve Univ, Sch Med, Cleveland, OH USA
Weiner, M:
Univ Texas Hlth Sci Ctr San Antonio, San Antonio, TX 78229 USA
S Texas VAMC, San Antonio, TX USA
Bozeman, L:
Ctr Dis Control & Prevent, Atlanta, GA USA
Heilig, CM:
Ctr Dis Control & Prevent, Atlanta, GA USA
Feng, PJ:
Ctr Dis Control & Prevent, Atlanta, GA USA
Moro, R:
Ctr Dis Control & Prevent, Atlanta, GA USA
Narita, M:
Univ Washington, Seattle, WA 98195 USA
Nahid, P:
Univ Calif San Francisco, San Francisco, CA 94143 USA
Ray, S:
Emory Univ, Sch Med, Atlanta, GA USA
Bates, E:
Univ N Texas, Denton, TX 76203 USA
Haile, B:
Westat Corp, Rockville, MD USA
Vernon, A:
Ctr Dis Control & Prevent, Atlanta, GA USA
Schluger, NW:
Columbia Univ, Med Ctr, New York, NY USA
Sambeat, MA:
Institut d’Investigació Biomèdica Sant Pau (IIB SANT PAU), Sant Quintí 77-79, 08041 Barcelona, Spain
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