High-Dose Rifampicin for 3 Months after Culture Conversion for Drug-Susceptible Pulmonary Tuberculosis
- Author:
Nakwon KWAK
1
;
Joong-Yub KIM
;
Hyung-Jun KIM
;
Byoung-Soo KWON
;
Jae Ho LEE
;
Jeongha MOK
;
Yong-Soo KWON
;
Young Ae KANG
;
Youngmok PARK
;
Ji Yeon LEE
;
Doosoo JEON
;
Jung-Kyu LEE
;
Jeong Seong YANG
;
Jake WHANG
;
Kyung Jong KIM
;
Young Ran KIM
;
Minkyoung CHEON
;
Jiwon PARK
;
Seokyung HAHN
;
Jae-Joon YIM
Author Information
- Publication Type:Original Article
- From:Tuberculosis and Respiratory Diseases 2025;88(1):170-180
- CountryRepublic of Korea
- Language:English
-
Abstract:
Background:This study aimed to determine whether a shorter high-dose rifampicin regimen is non-inferior to the standard 6-month tuberculosis regimen.
Methods: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 <6% difference in unfavorable outcomes rates. The study is registered with ClinicalTrials.gov (NCT04485156)
Results:Between 4 November 2020 and 3 January 2022, 76 participants were enrolled. Of these, 58 were included in the modified intention-to-treat analysis. Unfavorable outcomes occurred in 10 (31.3%) of 32 in the control group and 10 (38.5%) of 26 in the investigational group. The difference was 7.2% (95% confidence interval, ∞ to 31.9%), failing to prove non-inferiority. Serious adverse events and grade 3 or higher adverse events did not differ between the groups.
Conclusion:The shorter high-dose rifampicin regimen failed to demonstrate non-inferiority but had an acceptable safety profile.
