High-dose rifampicin for 3 months after culture conversion for drug-susceptible pulmonary tuberculosis

This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacteriu...

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Published in:Tuberculosis and respiratory diseases 2025, 88(1), 401, pp.170-180
Main Authors: Kwak, Nakwon, Kim, Joong-Yub, Kim, Hyung-Jun, Kwon, Byoung-Soo, Lee, Jae Ho, Mok, Jeongha, Kwon, Yong-Soo, Kang, Young Ae, Park, Youngmok, Lee, Ji Yeon, Jeon, Doosoo, Lee, Jung-Kyu, Yang, Jeong Seong, Whang, Jake, Kim, Kyung Jong, Kim, Young Ran, Cheon, Minkyoung, Park, Jiwon, Hahn, Seokyung, Yim, Jae-Joon
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내과학
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container_end_page 180
container_issue 1
container_start_page 170
container_title Tuberculosis and respiratory diseases
container_volume 88
creator Kwak, Nakwon
Kim, Joong-Yub
Kim, Hyung-Jun
Kwon, Byoung-Soo
Lee, Jae Ho
Mok, Jeongha
Kwon, Yong-Soo
Kang, Young Ae
Park, Youngmok
Lee, Ji Yeon
Jeon, Doosoo
Lee, Jung-Kyu
Yang, Jeong Seong
Whang, Jake
Kim, Kyung Jong
Kim, Young Ran
Cheon, Minkyoung
Park, Jiwon
Hahn, Seokyung
Yim, Jae-Joon
description This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen. This multicenter, randomized, open-label, non-inferiority trial enrolled participants with respiratory specimen positivity by Xpert MTB/RIF assay or Mycobacterium tuberculosis culture without rifampicin-resistance. Participants were randomized at 1:1 to the investigational or control group. The investigational group received high-dose rifampicin (30 mg/kg/day), isoniazid, and pyrazinamide until culture conversion, followed by high-dose rifampicin and isoniazid for 12 weeks. The control group received the standard 6-month regimen. The primary outcome was the rate of unfavorable outcomes at 18 months post-randomization. The non-inferiority margin was set at
doi_str_mv 10.4046/trd.2024.0099
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title High-dose rifampicin for 3 months after culture conversion for drug-susceptible pulmonary tuberculosis
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