Drug-susceptible pulmonary tuberculosis
Conditions
Interventions
Experimental group:Bedaquinoline, linezolid, isoniazid, pyrazinamide and citafloxacin were used for 2 months (2BLHZS).
Control group:Stardard treatment including Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE/4HR).
Sponsors
Third People’s Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18 to 65. 2. Clinical symptoms and/or lung imaging (chest radiograph or chest CT) support the diagnosis of active pulmonary tuberculosis. 3. The GeneXpert MTB/RIF test of respiratory tract samples was positive for MTB. 4. Voluntarily sign the informed consent to participate in the project, and be able and willing to accept follow-up visits. 5. Be willing to get tested for HIV. 6. Be willing to save samples, including DNA. 7. For fertile women, a negative serum or urine pregnancy test is required within 3 days of entering the study and a willingness to use effective contraception during the study period. Female subjects who are infertile must have a record of menopause, hysterectomy or bilateral oophorectomy, or bilateral tubal ligation. Acceptable forms of contraception include: condoms, intrauterine devices, cervical caps with spermicide, diaphragms with spermicide, etc.
Exclusion criteria
Exclusion criteria: 1. Prior to this study, patients had active tuberculosis and had received anti-tuberculosis therapy (including first - and second-line anti-tuberculosis drugs). 2. Known resistance, intolerance, or allergy to one or more anti-TB drugs, including isoniazid, rifampicin, rifapentine, pyrazinamide, ethambutol, fluoroquinolones, Bedaquinoline, linezolid, or contezolid prior to initiation of treatment. 3. Patients with hematogenous disseminated tuberculosis or with extrapulmonary tuberculosis (as specified in this study, the scope of tuberculosis includes: simple tuberculosis, tuberculosis + tuberculous pleurisy/bronchial tuberculosis/mediastinal lymphatic tuberculosis). Extrapulmonary tuberculosis refers to tuberculosis outside the chest area mentioned above). 4. Pulmonary infection associated with non-tuberculous mycobacterium or other microorganisms that affect treatment outcome. 5. Currently use drugs that affect the efficacy observation of this study or have contraindications. 6. Take any immunosuppressive drugs or systemic glucocorticoids for more than 2 weeks prior to screening. 7. Currently use or plan to use the drugs that is known to significantly prolong the QTc interval, including, but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, Cisapride, dipyramine, erthyrthromycin, procaine, quinidine, or sotalol. 8. Patients with diabetes mellitus who has poor control of blood glucose, and the researchers judged that it is unlikely to improve. 9.HIV positive. 10. Complicated with severe autoimmune diseases, severe hepatic and renal insufficiency, psychiatric diseases, hematological diseases and malignant tumors. 11. Laboratory parameters within 14 days prior to recruitment: (1) Serum AST and ALT >=3 times the upper limit of normal (ULN); (2) Creatinine >=2 times the upper limit of normal value; (3) Hemoglobin =5.5mmol/L, or =450ms (a re-test is allowed during the screening stage to re-evaluate eligibility); Having one or more risk factors for QT prolongation, such as arrhythmia or myocardial ischemia; A history or family history of long QT syndrome. 14. Women who are pregnant or breastfeeding. 15. Weight < 30kg, or =90kg. 16. The patient had participated in other drug clinical trials within 3 months of the screening period. 17. Other conditions for participations in the study is not considered appropriate by the study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy;safety; | — |
Countries
China
Contacts
Public ContactShuihua Lu
Third People’s Hospital of Shenzhen
Outcome results
None listed