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

Inclusion Criteria:

1. At least 19 years old at enrolment
2. Bodyweight over 35Kg
3. If rifampicin resistance is confirmed through molecular or phenotypic drugsusceptibility testing conducted on sputum or bronchoscopy specimens within 3 monthsof screening
4. Chest radiological findings consistent with pulmonary tuberculosis

Exclusion Criteria:

1. Uncontrolled DM
2. Extrapulmonary TB that would require treatment longer than would be usual forpulmonary TB
3. Less than 30 Karnofsky score at enrolment
4. BMI less than 17
5. Known severe allergy to any of the BPaLM regimen drugs
6. Medical history of Glucose-galactose malabsorption, galactose intolerance, and Lapplactase deficiency
7. HIV-positive
8. The QTcF interval exceeds 450 msec on the electrocardiogram at baseline
9. Patients who are at risk of Torsade de Pointes due to underlying heart diseases suchas heart failure or arrhythmia
10. For women of childbearing potential if the pregnancy test is positive, women who arebreastfeeding or planning to become pregnant within 6 months ofdiscontinuation/termination of treatment during the study, or who do not wantcontraception (i.e., oral and subcutaneous hormonal contraceptives, condoms,diaphragms, intrauterine device, or use of appropriate contraceptive methods includingabstinence) *Note: Double contraception (e.g., when a male uses a barrier contraceptive methodsuch as a condom, a female partner uses a hormonal contraceptive or an additionalcontraceptive method such as an intrauterine device) is required while taking thestudy drug and up to 6 months after stopping/terminating the study drug. Inparticular, taking the study drug may affect the efficacy of hormonal contraceptives,and even if you are using only barrier contraception at the same time with yourpartner, you cannot be sure of preventing pregnancy, so it is necessary to maintaindouble contraception.
11. Men who plan to become pregnant during the study period or within 6 months ofdiscontinuation/termination of treatment, or who do not wish to use doublecontraception or abstinence during this period.
12. Patients who have Grade 3 or 4 or higher peripheral neuritis, or Grade 1 or 2 with ahigh probability of progression to peripheral neuritis,
13. Current use of monoamine oxidase Inhibitor or used 2 weeks before treatment
14. Use of serotonergic antidepressant within 3 days of treatment
15. Any contraindication that may affect QTc interval (amiodarone, chloroquine,chlorpromazine, clarithromycin, haloperidol, etc.)
16. Any contraindication that may cause myelosuppression
17. Taking drugs that affect the cytochrome P450 enzyme within 30 days (quinidine,tyramine, ketoconazole, fluconazole, testosterone, quinine, gestodene, metyrapone,phenelzine, doxorubicin, troleandomycin, cyclobenzaprine, erythromycin, cocaine,furafylline, cimetidine, dextromethorphan, etc.)
18. Previously treated with Bedaquiline or Linezolid for more than 4 weeks
19. Abnormal value of a blood test at baseline:

• Hypokalemia, Hemoglobin < 8.0 g/dL, Platelet < 75,000/mm3, ANC < 1000/mm3
• AST or ALT > 3 X ULN, Total bilirubin >2.0 X ULN, Albumin < 3.2 mg/dL
• Serum creatinine > 2 X ULN, Serum calcium < LLN, Serum magnesium < LLN