Ultra-Short Regimen for Elderly DS-TB

Inclusion criteria

• Aged 65 years or older, regardless of gender
• Clinical symptoms and/or pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis;
• Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, and susceptible to rifampicin; Recommend using respiratory specimens for GeneXpert MTB/RIF testing;
• Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits;
• Willing to undergo HIV testing;
• Willing to preserve samples including DNA;

Exclusion criteria

• Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including first-line and second-line anti-tuberculosis drugs);
• Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, pyrazinamide, etc);
• Resistance to any investigational drug (i.e., bedaquiline, linezolid, pyrazinamide, etc). The following detection methods can be used: tNGS or other drug sensitivity testing methods (such as GeneXpert MTB/XDR, dissolution curve method, phenotypic drug sensitivity, etc.);
• Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary tuberculosis + tuberculous pleurisy/bronchial tuberculosis/mediastinal lymph node tuberculosis. Extrapulmonary tuberculosis refers to tuberculosis other than the chest-related types mentioned above);
• Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;
• Simultaneously using drugs that affect the efficacy of this study or have contraindications for combination therapy;
• Use of any immunosuppressive medication or systemic glucocorticoids for more than 2 weeks before screening;
• 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, itraconazole, procaine, quinidine, or sotalol;
• Uncontrolled blood sugar in diabetes, with no likelihood of improving blood sugar status according to the judgment of the researchers;
• HIV positive;
• Coexisting with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, or malignant tumors;
• 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 ULN; (3) Hemoglobin ≤ 70 g/L; (4) Platelet count ≤ 50 × 10^9/L; (5) Blood potassium levels are ≥ 5.5 mmol/L or ≤ 3.5 mmol/L;
• ECG QTcF ≥450 ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); Presence of one or more risk factors that could cause QT interval prolongation, such as arrhythmia, myocardial ischemia, etc.; history or family history of long QT syndrome;
• Weight <30 kg, or ≥90 kg;
• The patient has participated in clinical trials of other drugs within the past 3 months during the screening period;
• Other conditions deemed unsuitable for participation in the study by the research doctors.