Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis

Korábbi kezelés

• Evidence of concurrent extrapulmonary TB
• Subjects who have participated in other clinical studies within 8 weeks before the screening period
• Patients who cannot receive oral therapy
• Subjects who have used drugs known to prolong the QTcF interval for more than 3 days within 30 days before the screening period (including but not limited to amiodarone, bisoprolol, chloroquine, chlorpromazine, cisapride, cyclobenzaprine, clarithromycin, digoxin, dofetilide, domperidone, ertapenem, ibutilide, levomethadone, methadone, pentamidine, quinidine, sotalol, sparfloxacin, thioridazine)
• Subjects who have used any drug or substance known to be a strong inhibitor of cytochrome P450 enzymes within 30 days before the screening period (including but not limited to ritonavir, ketoconazole, itraconazole, voriconazole, clarithromycin, fluvoxamine, warfarin, rivaroxaban, and other novel oral anticoagulants)

Más betegség

• Confirmed resistance of mycobacterium tuberculosis isolates to any of the following: Isoniazid, fluoroquinolones, revealed by molecular drug susceptibility testing
• Known allergy or intolerance to any study drug
• Combined heart failure, coronary artery disease, myocardial infarction, ventricular hypertrophy, clinically significant arrhythmia, poorly controlled hypertension-related cardiovascular disease
• Subjects with known bleeding disorders or family history of bleeding disorders
• Subjects with HIV infection
• Subjects with known optic neuritis, history of alcoholism, gout, epilepsy, mental illness, porphyria, myasthenia gravis, or malignant tumors

Laborértékek

• Abnormal liver function (alanine transaminase [ALT], alkaline phosphatase [ALP], or total bilirubin [TBil] exceeding 2 times the upper limit of normal) or known cirrhosis or known alcoholic hepatitis
• The hematology indicates white blood cells <3.0×10⁹/L, or hemoglobin <80 g/L, or platelets <80×10⁹/L
• The estimated glomerular filtration rate (eGFR) is less than 60 mL/min/1.73 m²
• The blood electrolyte test indicates a baseline serum potassium level less than 3.5 mmol/L
• Patients with known QT prolongation syndrome or a family history thereof
• Patients with type I or type II diabetes, or HbA1c ≥6.5%, or random blood glucose ≥11.1 mmol/L with typical diabetic symptoms

Egyéb

• Subjects with clinically significant ECG abnormalities as determined by the investigator, including but not limited to: baseline QTcF >450 ms for males or >470 ms for females, presence of second- or third-degree atrioventricular block, QRS duration >120 ms
• Pregnant or lactating patients

• Age ≥18 years and ≤60 years
• Male or female
• Body weight 40-90 kg
• Capable of producing adequate sputum, with collection of at least 10ml overnight sputum
• Willing to participate in trial treatment and follow-up, with signed informed consent (legal guardian may sign for patients lacking civil capacity)
• Positive acid-fast bacilli smear microscopy of respiratory specimens (≥1+ according to WHO criteria) and positive rapid amplification test for Mycobacterium tuberculosis in respiratory specimens
• Rifampicin-susceptible based on molecular drug susceptibility testing or conventional drug susceptibility testing
• No anti-TB treatment for more than 3 days received within 6 months before the screening period
• Subjects whose imaging findings meet the diagnostic criteria for TB, as determined by the investigator
• Women of childbearing potential who have not undergone surgical sterilization must agree to use appropriate contraceptive methods