This study aims to compare the efficacy and safety of a 6-month all-oral regimen including Bedaquiline (BDQ,B), Delamanid (DLM,D), Linezolid (LZD, L), and Levofloxacin (LFX,L) to the the standard long - course treatment regimen within the Chinese population. The main questions it aims to answer are:
Is the efficacy of short regimen non-inferior to standard regimen? Is the short regimen safe enough to replace the standard regimen?
Participants will:
Be given with either short or standard regimen for RR-TB treatment Be asked to complete the scheduled visit as planned.
Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions will be included.
Aged between 18 and 65 years old.
Have never used bedaquiline, delamanid, linezolid, or levofloxacin in the past, or have used them for no more than 4 weeks.
Positive results of mycobacterial culture (either smear-positive or smear-negative) within the recent one month, and no effective anti-tuberculosis treatment received within this one-month period; or in the absence of recent sputum culture results, smear-positive sputum and no effective anti-tuberculosis treatment administered.
Individuals with a history of optic neuropathy or peripheral neuropathy, whom the researchers believe may experience progression/worsening during the study or are not suitable for participation in this research.
Chronic active hepatitis, with positive results for three items: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and hepatitis B core antibody (anti - HBc), or HBV - DNA > 1000 CPs/mL, accompanied by elevated ALT/AST. Elevation of ALT or AST is ≥3 times the upper limit of the normal value, or elevation of total bilirubin and direct bilirubin is ≥2 times the upper limit of the normal value (if it is a temporary elevation, patients can be enrolled after recovery from treatment).
Severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 mL/min).
Individuals who have participated in clinical trials of other unlisted new drugs within the past three months.
Parallel
bedaquiline
DrugAdminister 400 mg orally once daily for 2 weeks, followed by 200 mg orally three times a week for 22 weeks
Delamanid (DLM)
DrugAdminister 100 mg orally, twice daily for 24 weeks.
Linezolid (LZD)
DrugAdminister 600 mg orally, once daily for 24 weeks.
Levofloxacin
Drugtest group:Administer 800 mg orally, once daily for 24 weeks;control group:Administer 800 mg orally, once daily for 72 weeks
Cycloserine
DrugAdminister 250mg orally, twice daily for 72 weeks.
Clofazimine
DrugAdminister 100 mg orally, once daily for 72 weeks
End of treatment outcome
Number of individuals experiencing each tuberculosis treatment outcome (cure, completion, death, failure, lost-to-follow-up), assessed at the end of treatment by a clinician, based on culture results
The median time to Sputum Culture Conversion
time from treatment initiation to the first of two consecutive negative sputum cultures without an intervening positive culture in liquid media
Final tuberculosis treatment outcome
Number of individuals experiencing each final tuberculosis treatment outcome (cure, completion, death, failure, lost-to-follow-up, relapse), assessed at 24, 48, and 72 weeks by a clinician, based on culture results
The frequency of grade 3 or greater adverse events among patients
Assessed by a clinician based on symptomatology, subjective screening, and/or laboratory findings during treatment or follow-up. Adverse events are referenced against CTCAE 5.0.
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