Tuberculosis
Conditions
Interventions
Experimental Group:BLSZ regimen for 2 months (9 weeks), may be extended to 3 months (13 weeks) if necessary.
Control Group:6BPaLM (26 weeks
may be extended to 9 months / 39 weeks if necessary),Use Bedaquiline, Protomanib, Linezolid, and Moxifloxacin throughout the entire process.
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, male or female. 2. Clinical symptoms and/or chest imaging (chest X-ray or chest CT) supporting a diagnosis of active pulmonary tuberculosis. 3. Mycobacteriological tests (molecular or phenotypic) confirming the presence of Mycobacterium tuberculosis with rifampicin resistance; 4. GeneXpert MTB/RIF assay using respiratory specimens is recommended.Voluntarily sign the informed consent form for study participation, and be able and willing to complete all follow-up visits. 5. Willing to undergo HIV testing. 6. Willing to store biological samples including DNA. 7. For women of childbearing potential: negative serum or urine pregnancy test within 3 days prior to study enrollment, and willingness to use effective contraceptive measures throughout the study period. For female subjects of non-childbearing potential: documentation of menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be provided. Acceptable forms of contraception include condoms, intrauterine devices (IUDs), cervical cap with spermicide, diaphragm with spermicide, etc.
Exclusion criteria
Exclusion criteria: 1. History of active pulmonary tuberculosis with prior anti-tuberculosis treatment. 2. Intolerance or allergy to the study drugs (bedaquiline, linezolid, fluoroquinolones [moxifloxacin / sitafloxacin], pyrazinamide). 3. Drug resistance to the above study drugs (confirmed by tNGS, GeneXpert MTB/XDR, melting curve analysis, phenotypic DST, or other applicable methods). 4. Hematogenous disseminated tuberculosis or extrapulmonary tuberculosis outside the study definition. 5. Concurrent NTM infection or other pulmonary infections that may affect study outcomes. 6. Concomitant use of medications that interfere with efficacy evaluation or have contraindications for combined use. 7. Use of immunosuppressive agents or systemic glucocorticoids for = 2 weeks prior to screening. 8. Current use or planned use of drugs known to cause significant QTc prolongation. 9. Poorly controlled diabetes mellitus deemed difficult to improve by the investigator. 10. HIV-positive status. 11. Severe autoimmune disease, severe hepatic or renal insufficiency, psychiatric disorder, hematological disease, or malignant tumor. 12. Abnormal laboratory results within 14 days prior to screening:AST/ALT = 3 × ULN;creatinine = 2 × ULN;Hb = 70 g/L;PLT = 50 × 10?/L;serum potassium = 5.5 or = 3.5 mmol/L. 13. QTcF = 450 ms (one repeat measurement permitted during screening), or presence of high risk factors for QT prolongation, history or family history of long QT syndrome. 14. Pregnancy or lactation. 15. Body weight < 30 kg or = 90 kg. 16. Participation in another investigational drug trial within 3 months prior to screening. 17. Any other conditions deemed inappropriate for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients experiencing adverse outcomes (failure, death, loss to follow-up) 12 months (52 weeks) after randomization;Percentage of patients who have treatment interruption due to any reason or died within 2 months (9 weeks) after randomization;Liver function damage during treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sputum culture conversion rate;Cultivate conversion time (Median time);Unfavorable outcomes (short-term);Unfavorable outcomes (mid-term);Serious adverse events or grade 3 or higher adverse events (short-term);Serious adverse events or grade 3 or higher adverse events (mid-term);QTcF prolongation during treatment; | — |
Countries
China
Contacts
Public ContactLu Shuihua
Shenzhen Third People's Hospital
Outcome results
None listed