부산대학교 도서관

BACKGROUND Tuberculosis is usually treated with a 6-month ritampin-based regimen. Whether a strategy involving shorter initial treatment may lead to similar outcomes is unclear. METHODS In this adaptive, open-label, noninferiority trial, we randomly assigned partici-pants with rifampin-susceptible pulmonary tuberculosis to undergo either standard treatment (rifampin and isoniazid for 24 weeks with pyrazinamide and ambutol for the first 8 weeks) or a strategy involving initial treatment with 8-week regimen, extended treatment for persistent clinical disease, monitoring after treatment, and retreatment for relapse. There were four strategy groups with different initial regimens; noninferiority was assessed in the two strategy groups with complete enrollment, which had initial regimens of high-dose rifampin-line-zolid and bedaquiline-linezolid (each with isoniazid, pyrazinamide, and ethambu-tol). The primary outcome was a composite of death, ongoing treatment, or active disease at week 96. The noninferiority margin was 12 percentage points. RESULTS Of the 674 participants in the intention-to-treat population, 4 (0.6°/o) withdrew consent or were lost to follow-up. A primary-outcome event occurred in 7 of the 181 participants (3.996) in the standard-treatment group, as compared with 21 of the 184 participants (11.4%) in the strategy group with an initial rifampin-linezolid regimen (adjusted difference, Z4 percentage points; 97.5°/o confidence interval [CI], 1.7 to 13.2; noninferiority not met) and 11 of the 189 participants (5.8°6) in the strategy group with an initial bedaquiline-linezolid regimen (adjusted difference, 0.8 percentage points; 97.5% CI, -3.4 to 5.1; noninferiority met). The mean total duration of treatment was 180 days in the standard-treatment group, 106 days in the rifampin-linezolid strategy group, and 85 days in the bedaquilinelinezolid strategy group. The incidences of grade 3 or 4 adverse events and serious adverse events were similar in the three groups. CONCLUSIONS A strategy involving initial treatment with an 8-week bedaquiline-linezolid regimen was noninferior to standard treatment for tuberculosis with respect to clinical outcomes. The strategy was associated with a shorter total duration of treatment and with no evident safety concerns. (Funded by the Singapore National Medical Research Council and others; TRUNCATE-TB Clinicall'rials.gov number, NCT03474198.). [ABSTRACT FROM AUTHOR]