BPaL(M) Regimen for the Treatment of MDR/RR-TB
NCT05381194 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-03-15
Summary
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.
Conditions
- Multidrug- and Rifampicin-resistant Tuberculosis
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
Pusan National University Hospital
collaborator OTHER -
Samsung Medical Center
collaborator OTHER -
Seoul National University Hospital
collaborator OTHER -
Severance Hospital
collaborator OTHER -
Chonnam National University Hospital
collaborator OTHER -
The Catholic University of Korea
collaborator OTHER -
Chungbuk National University Hospital
collaborator OTHER -
Ulsan University Hospital
collaborator OTHER -
Soon Chun Hyang University
collaborator OTHER -
Incheon St.Mary's Hospital
collaborator OTHER -
DongGuk University
collaborator OTHER -
National Medical Center, Seoul
collaborator OTHER -
Asan Medical Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-13
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- South Korea
Study Locations
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