Pulmonary tuberculosis
Conditions
Interventions
Group A:Two-month BLSZ regimen: oral bedaquiline, linezolid, sitafloxacin, and pyrazinamide. The safe and effective dose of pyrazinamide will be recommended by a clinical decision support system. At 2
Group B:Three-month HPSZ regimen with rifapentine 1200 mg/day: oral isoniazid, rifapentine 1200 mg/day, sitafloxacin, and pyrazinamide. The safe and effective dose of pyrazinamide will be recommended
Group C:Three-month HPSZ regimen with rifapentine 900 mg/day: oral isoniazid, rifapentine 900 mg/day, sitafloxacin, and pyrazinamide. The safe and effective dose of pyrazinamide will be recommended by
Group D:Standard 2HRZE/4HR regimen: oral isoniazid, rifampicin, pyrazinamide, and ethambutol during the first 2-month intensive phase, followed by oral isoniazid and rifampicin during the subsequent 4
Sponsors
Shenzhen Third People’s Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria: 1. Aged 60 to 90 years, regardless of sex; 2. Clinical symptoms and/or pulmonary imaging findings, including chest radiography or chest CT, supporting a diagnosis of active pulmonary tuberculosis; 3. Microbiological evidence, by molecular or phenotypic testing, confirming the presence of *Mycobacterium tuberculosis*, with at least rifampicin susceptibility confirmed. GeneXpert MTB/RIF testing or MGIT 960 mycobacterial culture and drug susceptibility testing using respiratory specimens is recommended; 4. Voluntarily signs the informed consent form and is able and willing to attend follow-up visits; 5. Willing to undergo HIV testing and confirmed to be HIV negative; 6. Willing to provide study-related samples, including DNA samples; 7. For participants who are unable to live independently or have limited mobility, authorization from a guardian is required.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded: 1. Receiving anti-tuberculosis treatment for active pulmonary tuberculosis for more than 2 weeks; 2. Existing evidence of intolerance or allergy to any study drug; 3. Existing evidence of resistance to any drug included in the study regimens; 4. Presence of miliary/disseminated tuberculosis or concomitant extrapulmonary tuberculosis; 5. Concomitant non-tuberculous mycobacterial (NTM) infection or other microbial pulmonary infections that may affect treatment outcomes; 6. Concomitant use of medications that may interfere with efficacy assessment in this study or are contraindicated for co-administration with the study drugs; 7. Use of immunosuppressive agents or systemic glucocorticoids for more than 2 weeks before screening; 8. Current or planned use of any medication known to markedly prolong the QTc interval; 9. Poorly controlled diabetes mellitus that, in the investigator’s judgment, is unlikely to improve; 10. Severe autoimmune disease, severe hepatic impairment [ALT/AST >3 times the upper limit of normal and/or TBIL >2 times the upper limit of normal, or Child-Pugh class B or C cirrhosis], renal impairment (eGFR =50 ml/min), severe psychiatric disease, severe hematologic disease, or malignancy, except for radically treated carcinoma in situ; 11. QTcF >=450 ms on a 12-lead electrocardiogram during screening; or a clear high-risk condition for QT interval prolongation, including a personal or family history of long QT syndrome, clinically significant arrhythmia, uncontrolled or unstable myocardial ischemia/heart failure, second-degree type II or third-degree atrioventricular block, or persistent hypokalemia, hypomagnesemia, or hypocalcemia despite correction; 12. Body weight =90 kg; 13. Any other condition that, in the investigator’s judgment, makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Culture conversion rate at 2 months (week 9) after randomization;Rate of treatment discontinuation or death within 2 months (week 9) after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of unfavorable outcomes at 6 months (week 26) after randomization;Rate of unfavorable outcomes at 12 months (week 52) after randomization;Rate of unfavorable outcomes at 24 months after randomization;Median time to culture conversion; | — |
Countries
China
Contacts
Public ContactShuihua Lu
Shenzhen Third People’s Hospital
Outcome results
None listed