drugset / Trial / NCT05381194
BPaL(M) Regimen for the Treatment of MDR/RR-TB
Phase 4
Recruiting
80 enrolled
Asan Medical Center
Chonnam National University Hospital · collabChungbuk National University Hospital · collabDongGuk University · collabIncheon St.Mary's Hospital · collabNational Medical Center, Seoul · collabPusan National University Hospital · collabSamsung Medical Center · collabSeoul National University Hospital · collabSeverance Hospital · collabSoon Chun Hyang University · collabThe Catholic University of Korea · collabUlsan University Hospital · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-12-13
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 200 mg | — |
| Subject | Linezolid | Other / unclassified | 300 mg | — |
| Subject | Moxifloxacin | Small molecule | 400 mg | — |
| Subject | Pretomanid | Small molecule | 200 mg | — |