The objective of this study is to analyze the efficacy of a new regimen using Bedaquiline, Pretomanid, Linezolid, and Moxifloxacin for 24 weeks or Bedaquiline, Pretomanid, Linezolid for 26 weeks for the treatment of MDR/RR-TB through the clinical trial.
The BPaL (Bedaquiline, Pretomanid, Linezolid) regimen has been proven effective for the treatment of Fluoroquinolone-resistant MDR-TB through studies such as the NixTB and ZeNix trials. In addition, the BPaLM regimen has been demonstrated to have excellent efficacy in RR-TB patients through the TB-PRACTECAL study. This study aims to analyze the efficacy of the BPaL(M) regimen in Korean MDR/RR-TB patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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
Asan Medical Center
Seoul, Songpa-gu, South Korea
RECRUITINGA microbiological failure or clinical failure or relapse
A microbiological failure or clinical failure or relapse during the treatment period and the 12-month follow-up period after end of treatment
Time frame: until 12 months after the end of treatment
Time to sputum culture conversion during the treatment period
Analyze the time to liquid and solid culture conversion and estimate the median value using the Kaplan-Meier Method
Time frame: 26 weeks or 24 weeks
Proportion of culture-negative patients at specific times (weeks 4, 8, 12, 16, and 24 or 26)
Frequency analysis of liquid and solid culture conversion at a specific time point
Time frame: 26 weeks or 24 weeks
Prescribed dose of Linezolid
Analyze the actual dose of linezolid prescribed
Time frame: 26 weeks or 24 weeks
All-cause mortality
Analyze the frequency and fraction of deaths and estimate the median using the Kaplan-Meier Method
Time frame: 26 weeks or 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.