80
Participants
Start Date
December 13, 2022
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
BPaL(M) regimen
"Patients diagnosed with MDR/RR-TB are initially assigned to the BPaLM regimen as a single-arm for treatment initiation. Afterward, if MDR/RR-TB is confirmed to be fluoroquinolone-resistant by molecular or phenotypic DST, the treatment is switched to the BPaL regimen (for 24 weeks). On the other hand, if MDR/RR-TB is confirmed to be fluoroquinolone-susceptible, treatment for MDR/RR-TB is maintained with the BPaLM regimen (for 26 weeks).~The dosage of each medication is as follows:~* Bedaquiline 400mg/day for the 2 weeks, 200mg/TIW afterward~* Pretomanid 200mg/day~* Linezolid 600mg/day for the 9weeks, 300mg/day afterward~* Moxifloxacin 400mg/day"
RECRUITING
Asan Medical Center, Seoul
Lead Sponsor
Pusan National University Hospital
OTHER
Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER
Severance Hospital
OTHER
Chonnam National University Hospital
OTHER
The Catholic University of Korea
OTHER
Chungbuk National University Hospital
OTHER
Ulsan University Hospital
OTHER
Soon Chun Hyang University
OTHER
Incheon St.Mary's Hospital
OTHER
DongGuk University
OTHER
National Medical Center, Seoul
OTHER
Asan Medical Center
OTHER