Tuberculosis
Conditions
Interventions
Expriment group (A):4 BDMZ/6 BDL
Control group (B):6 BDLLfx/Cfz
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 6 to 70 years old, male or female; 2) Patients diagnosed with active pulmonary tuberculosis after comprehensive clinical evaluation (including clinical symptoms and/or lung imaging [chest X-ray or chest CT]) and need to initiate anti-tuberculosis therapy with drug-resistant regimens; Note 1: No distinction is made between treatment-naïve or re-treated cases; Note 2: In this study, the scope of pulmonary tuberculosis includes: pulmonary tuberculosis, tuberculous pleurisy, bronchial tuberculosis, and mediastinal lymph node tuberculosis. Extrapulmonary tuberculosis refers to the exclusion of tuberculosis beyond the chest range mentioned above; Note 3: Extrapulmonary tuberculosis (such as hematogenous disseminated tuberculosis, osteoarticular tuberculosis, tuberculous pericarditis, etc.) cannot be included in this study, and neurological tuberculosis (such as tuberculous meningitis, tuberculous meningitis, etc.) cannot be included in this study. 3) Microbiological testing confirmed the presence of Mycobacterium tuberculosis, and antimicrobial susceptibility testing (including various reliable molecular antimicrobial susceptibility tests, phenotypic antimicrobial susceptibility testing) confirmed rifampicin resistance; Preferential use of respiratory specimens for GeneXpert MTB/RIF testing is recommended; 4) Voluntarily sign the informed consent form to participate in the project, and be able and willing to accept follow-up visits; 5) For females of childbearing potential, a negative serum or urine pregnancy test within 3 days prior to study entry is required and willing to use effective contraception during the study. Female subjects of non-childbearing potential, must have documented menopause, hysterectomy or bilateral oophorectomy, or bilateral tubal ligation. Acceptable forms of contraception include: condoms, intrauterine devices, cervical caps plus spermicide, diaphragm plus spermicide, etc.
Exclusion criteria
Exclusion criteria: 1) Resistance to one or any combination of bedaquiline, delamanib, linezolid; Note 1: Regardless of whether fluoroquinolones (including moxifloxacin and levofloxacin) are resistant or not; Note 2: Prior to enrollment, various methods are allowed to detect resistance to the above drugs, including targeted gene sequencing (tNGS) or other antimicrobial susceptibility testing methods (e.g., GeneXpert MTB/XDR, dissolution curve method, WGS, phenotypic drug sensitivity, etc.). 2) intolerance or hypersensitivity to one or any combination of bedaquiline, delamanid, linezolid, moxifloxacin, levofloxacin, pyrazinamide; 3) neurological tuberculosis; 4) Extrapulmonary tuberculosis (such as hematogenous disseminated tuberculosis, osteoarticular tuberculosis, tuberculous pericarditis, etc.); 5) acute or chronic pulmonary infections that are not Mycobacterium tuberculosis or other microorganisms that affect the treatment outcome, among which, acute pulmonary infections can be enrolled in this study after cure; 6) Concurrent application of drugs that affect the observation of the efficacy of this study or have contraindications to the combination of drugs; 7) Take any immunosuppressive drugs or systemic glucocorticoids for more than 2 weeks before screening; 8) Any drug currently used or planned to be used that is known to cause QTc interval prolongation, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, disopyramide, oxothyromycin, procaine, quinidine or sotalol (see attachment for details); 9) Any psychiatric specialty medication currently used or planned to be used that is known to be in conflict with linezolid use, including but not limited to: fluoxetine, sertraline, citalopram, escitalopram, paroxetine; venlafaxine, duloxetine; phenelzine, propynylammine, isocarboxazide; bupropion; olanzapine, quetiapine, clozapine; amitriptyline, nortriptyline; lithium salts (see attachment for details); 10) Poor glycemic control of diabetes mellitus, and it is unlikely to improve the blood glucose status as judged by the investigator; 11) HIV-positive; 12) Severe autoimmune diseases, severe liver and kidney insufficiency, psychiatric diseases, hematologic diseases and malignant tumors; 13) 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 for adult males, >470ms for adult females, and 460ms for adolescents (= 15 years old, both male and female) > (during the screening phase, one retest is allowed to reassess eligibility); Have one or more risk factors for QT interval prolongation, such as arrhythmia, myocardial ischemia, etc.; Have a history or family history of long QT syndrome. 15) Females who are pregnant or breastfeeding; 16) Body weight=90kg; 17) The patient has participated in other drug clinical trials within 3 months of the screening period; 18) Other conditions that are considered unsuitable by the study doctor to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Early treatment response;Secondary safety outcome;All-cause mortality;QTcF prolongation; | — |
Countries
China
Contacts
Public ContactFu Liang
Shenzhen Third People's Hospital
Outcome results
None listed