Trials / Recruiting
RecruitingNCT05381194
BPaL(M) Regimen for the Treatment of MDR/RR-TB
The 6-month BPaL(M) Regimen for the Treatment of Patients With MDR/RR-TB: Multicenter, Single-arm, Operational Research, Clinical Trial
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Asan Medical Center · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-12-13
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2022-05-19
- Last updated
- 2024-03-15
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05381194. Inclusion in this directory is not an endorsement.