Clinical Research Directory

Inclusion Criteria: he research participants themselves voluntarily signed the informed consent form before being enrolled; for those without full capacity for civil conduct, the consent form was signed by their legal guardians. The research participants (and their guardians) indicated their willingness to complete all steps and intervention periods of the study. Male or female, aged 12 years or older, weighing 30 kilograms or more. Confirmed cases of pulmonary tuberculosis pathogen, with molecular or phenotypic drug sensitivity results within the past 3 months confirming resistance to rifampicin, and confirmed by the pathogen culture results of sputum collected at the time of enrollment. Fertile women not in pregnancy, voluntarily undergoing pregnancy tests, with negative results, and willing to use highly effective contraceptive measures from the time of signing the informed consent until 3 months after the end of the study treatment. For fertile men, use condoms or other methods to ensure effective contraception for their sexual partners. Women in lactation, willing to stop breastfeeding from the time of signing the informed consent until 3 months after the end of the study treatment. Voluntary to undergo HIV testing. If the result is positive, voluntarily accept antiretroviral therapy. Exclusion Criteria: Had a known hypersensitivity reaction to any drug in the protocol. Was participating in any clinical trial of other drugs. At the screening stage, had cardiovascular disease risk: QTcF interval over 480 milliseconds; within 60 days before enrollment, had a history of clinically significant arrhythmia that the investigator considered could be clinically significant, and the investigator considered that participating in the study might increase the risk; decompensated heart failure; grade 3 hypertension and not reaching the control target; thyroid dysfunction; abnormal serum calcium, magnesium or potassium levels. Had a history of optic nerve or peripheral nerve lesion, and the investigator considered that it might progress/deteriorate during the study or was not suitable for participating in this study. At the screening stage, had the following liver disease manifestations: active viral hepatitis; decompensated stage of liver cirrhosis. At the screening stage, had the following kidney disease history or kidney-related manifestations: unstable or rapidly progressive kidney disease history; moderate/severe renal function impairment or end-stage renal disease; male serum creatinine ≥ 133 μmol/L, female serum creatinine ≥ 124 μmol/L. Other laboratory test abnormalities: hemoglobin level \< 8.0 g/dL; platelet count \< 75,000/mm³; absolute neutrophil count \< 1000/mm³; aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 3×ULN; total bilirubin \> 2×ULN, or \> 1.5×ULN, combined with other liver enzyme abnormalities; albumin \< 30 g/L. The investigator considered that the study participants could not complete the study process, or participating in the study was unsafe for the study participants.