Tuberculosis
Conditions
Interventions
BJL Group:bedaquiline+JDB0131+linezolid
BJLC group:bedaquiline+JDB0131+linezolid+clofazimine
BJLM group:bedaquiline+JDB0131+linezolid+moxifloxacin
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participants diagnosed with active pulmonary tuberculosis based on comprehensive clinical evaluation (including clinical symptoms and/or chest imaging) and requiring initiation of multidrug-resistant tuberculosis treatment regimen; 2. Aged between 18 and 70 years; 3. Microbiological testing confirms the presence of Mycobacterium tuberculosis, with drug susceptibility testing confirming rifampicin resistance; 4. Voluntarily sign the informed consent form for this project and be able and willing to undergo follow-up visits; 5. For female participants of childbearing potential: a negative pregnancy test within 3 days prior to study initiation is required, and effective contraception (e.g., condoms, intrauterine devices) must be used during the study period. Women who are infertile must have documentation of menopause or relevant surgical procedures.
Exclusion criteria
Exclusion criteria: 1. Resistance exists to one or any combination of JDB0131 benzenesulfonate tablets, bedaquiline, linezolid, and clofazimine. Note 1: Regardless of fluoroquinolone resistance status; 2. Intolerance or allergy to JDB0131 benzenesulfonate tablets, bedaquiline, linezolid, clofazimine, or fluoroquinolones, either individually or in any combination; 3. Co-infection with non-tuberculous mycobacteria or other microorganisms affecting treatment outcomes; 4. Concurrent use of medications that may affect the efficacy assessment of this study or have contraindications for combination therapy; 5. Taking any immunosuppressant or systemic glucocorticoid for more than 2 weeks prior to screening; 6. Current or planned use of any medication known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, disopyramide, ergotamine, procaine, quinidine, or sotalol; 7. Poorly controlled diabetes mellitus with blood glucose levels unlikely to improve based on the investigator's judgment; 8. HIV-positive; 9. Concurrent severe autoimmune diseases, severe hepatic or renal impairment, psychiatric disorders, hematologic disorders, or malignancies; 10. Laboratory parameters within 14 days prior to enrollment: (1) Serum AST and ALT >= upper limit of normal (ULN); (2) Creatinine >=ULN; (3) Hemoglobin = 5.5 mmol/L or = 450 ms (one retest permitted during screening phase to reassess eligibility); presence of risk factors for QT interval prolongation, such as arrhythmia or myocardial ischemia; history or family history of long QT syndrome; 12. Women who are pregnant or breastfeeding; 13. Participants weighing =90 kg; 14. Participants who have participated in other drug clinical trials within 3 months of the screening period; 15. Participants deemed unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sputum smear;Sputum culture;Mycobacterium tuberculosis CFU count;Molecular Biology Testing for Mycobacterium tuberculosis(TB-RNA);Chest Imaging Examination; | — |
Countries
China
Contacts
Public ContactHe Jianqing
West China Hospital, Sichuan University
Outcome results
None listed