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RECRUITING
NCT05381194
PHASE4

BPaL(M) Regimen for the Treatment of MDR/RR-TB

Sponsor: Asan Medical Center

View on ClinicalTrials.gov

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.

Official title: The 6-month BPaL(M) Regimen for the Treatment of Patients With MDR/RR-TB: Multicenter, Single-arm, Operational Research, Clinical Trial

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2022-12-13

Completion Date

2027-12

Last Updated

2024-03-15

Healthy Volunteers

No

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

Locations (1)

Asan Medical Center

Seoul, Songpa-gu, South Korea