Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

Inclusion Criteria:

• Participants are willing to sign informed consent of this trial, those withoutcapacity for civil conduct need their legal guardian to sign

• Participants (and their legal guardian if applicable) are willing to cooperate tocomplete all trial procedures

• Male or female, 12 years or older, weight ≥ 30kg

• Confirmed pulmonary tuberculosis with resistance to rifampin by phenotypic orgenotypic susceptibility testing within 3 months, and must be re-confirmed by sputumculture sampled at trial inclusion

• Women with childbearing potential should not be pregnant, confirmed by a volunteerednegative pregnancy test, and are willing to use effective contraceptive method fromgiving consent to 3 months after study treatment

• Men with childbearing potential must be willing to use condom or other effectivecontraceptive methods to avoid their sex partners from being pregnant

• Women in breastfeeding period must be willing to discontinue breastfeeding fromgiving consent to 3 months after study treatment

• Participants are willing to take HIV test, and willing to take appropriateantiretroviral therapy if positive

Exclusion Criteria:

• Previously use of Bedaquiline or Delamanid for at least 28 days

• Concomitant hematogenous disseminated tuberculosis, or severe pulmonary tuberculosisin investigator's opinion (including tuberculosis of the digestive system,osteoarticular tuberculosis or tuberculous meningitis)

• Currently using any drug that has been prohibited in the protocol

• History of allergic action to any of the study drugs

• Currently participating in any other clinical trials

• Cardiovascular risk at screening: (1) QTcF more than 480 milliseconds (ms); (2)History of clinically significant arrythmia, and at investigator's opinion,participation in this study will increase the risk; (3) Decompensated heart failure; (4) Grade 3 high blood pressure and the goals of treatment have not been reached; (5) Abnormal thyroid function; (6) Abnormal serum Ca, Mg or K level; (7) Otherconditions with cardiovascular risks in investigator's opinion.

• History of optic neuropathy or peripheral neuropathy, and the investigator considersthat the condition may progress or deteriorate by participating in the study, orinappropriate to participate

• Hepatic disorders at screening: (1) Active viral hepatitis: HBsAg positive or HBVDNA >1000 CPs/mL, with elevated AST or ALT or HCV RNA positive; (2) Decompensatedcirrhosis

• Renal disorders at screening: (1) Unstable or rapidly progressive renal disease; (2)Moderate / severe renal disfunction or end-stage renal disease (eGFR< 60 mL/min/1.73m2); (3) Serum creatinine ≥133 μmol/L(1.5 mg/mL) in men, or ≥124 μmol/L (1.4 mg/mL)in women

• Other abnormal laboratory test: (1) Hemoglobin < 8.0g/dL; (2) Platelet <75,000/mm3; (3) Absolute neutrophil count <1000/mm3; (4) Aspartate transaminase (AST) or alanineaminotransferase (ALT) >3×upper limit of normal (ULN); (5) Total bilirubin (TBil) >2×ULN, or >1.5×ULN together with abnormal AST or ALT; (6) Albumin <30g/L

• The investigator considers that the participant is not able to complete the studyprocess, or the participation is not safe.