Tuberculosis
Conditions
Interventions
Drug-resistant group A:2 months (9 weeks) BLSZ. Bedaquiline, linezolid, sitafloxacin, and pyrazinamide are used throughout the process
Control group B:Control group (drug sensitive tuberculosis): 2HRZE/4HR (26 weeks). During the first two months of intensive treatment, isoniazid, rifampicin, pyrazinamide, and ethambutol were used as
During the consolidation period of the last 4 months, isoniazid and rifampicin were used for treatment
Control group C:6BPaLM (26 weeks),Use Bedaquiline, Protomanib, Linezolid, and Moxifloxacin throughout the entire process
Sensitive group A:2 months (9 weeks) BLSZ. Bedaquiline, linezolid, sitafloxacin, and pyrazinamide are used throughout the process
Sponsors
Shenzhen Third people's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 65 years old, regardless of gender; 2. Clinical symptoms and/or pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis; 3. Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, whether resistant to rifampicin or not; Recommend using respiratory specimens for GeneXpert MTB/RIF testing; 4.Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits; 5. Willing to undergo HIV testing; 6. Willing to preserve samples including DNA; 7.For women with fertility, they have a negative serum or urine pregnancy test within 3 days before enroll the study and be willing to use effective contraceptive measures during the study period. Female subjects without fertility must have records of menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. Acceptable forms of contraception include condoms, intrauterine devices, cervical caps with spermicides, and diaphragm with spermicides.
Exclusion criteria
Exclusion criteria: 1. Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and received anti-tuberculosis treatment (including first-line and second-line anti tuberculosis drugs); 2. There is intolerance or allergy to any investigational drug (i.e. bedaquiline, linezolid, fluoroquinolones [including moxifloxacin, sitagliptin], pyrazinamide); 3. There is resistance to any investigational drug (i.e. bedaquiline, linezolid, fluoroquinolones [including moxifloxacin, sitagliptin], pyrazinamide). The following detection methods can be used: tNGS or other drug sensitivity detection methods (such as GeneXpert MTB/XDR, dissolution curve method, phenotype drug sensitivity, etc.); 4. Suffering from hematogenous disseminated tuberculosis or combined with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary tuberculosis+tuberculous pleurisy/bronchial tuberculosis/mediastinal lymphotuberculosis. Extrapulmonary tuberculosis refers to tuberculosis excluding the above chest scope); 5. Merge non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes; 6. Simultaneously apply drugs that affect the efficacy observation of this study or have contraindications for combination therapy; 7.Take any immunosuppressive medication or systemic use of glucocorticoids for more than 2 weeks before screening; 8.Any medication currently used or planned to be used that is known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole, itracin, procaine, quinidine, or sotalol; 9.The blood sugar control of diabetes is not good, and it is unlikely to improve the blood sugar status according to the judgment of the researchers; 10.HIV positive; 11. Combined with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, and malignant tumors; 12. Laboratory parameters within 14 days prior to recruitment: (1). Serum AST and ALT levels >= 3 times the upper limit of normal (ULN); (2). Blood creatinine >= 2 times the upper limit of normal value; (3). Hemoglobin = 5.5 mmol/L or = 450ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); There are one or more risk factors that can cause QT interval prolongation, such as arrhythmia, myocardial ischemia, etc; History or family history of long QT syndrome; 14. Women who are pregnant or breastfeeding; 15. Weight= 90kg; 16. The patient has participated in clinical trials of other drugs within the screening period of 3 months; 17. Other situations that the research doctors deem unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unfavorable outcomes;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cultivate conversion rate;Unfavorable outcomes (short-term);Unfavorable outcomes (mid-term);Cultivate conversion time (Median time);Serious adverse events or grade 3 or higher adverse events (short-term);Serious adverse events or grade 3 or higher adverse events (mid-term);Adverse events during treatment;QTcF prolongation during treatment;Liver function damage during treatment; | — |
Countries
China
Contacts
Public ContactLu Shuihua
Shenzhen Third people's Hospital
Outcome results
None listed