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

Bedaquiline tablets administered orally. Dosing: 400 mg once daily for the first 2 weeks, then 200 mg three times per week for weeks 3-17. Used in both experimental arms (BZMD and BZMH groups) as part of the 4-month short-course regimen for drug-susceptible tuberculosis treatment.

Moxifloxacin 400 mg tablets administered orally once daily before or after meals throughout the entire treatment period (17 weeks). Used in both experimental arms (BZMD and BZMH groups) as part of the 4-month short-course regimen for drug-susceptible tuberculosis treatment.

Pyrazinamide tablets administered orally once daily in the morning during intensive phase (8 weeks). Dosing by weight: 1000 mg for 40.0-49.9 kg, 1500 mg for 50.0-70.9 kg, 2000 mg for ≥75.0 kg. Used in both experimental arms (BZMD and BZMH groups) and control group as part of tuberculosis treatment regimen.

Delamanid tablets administered orally at 100 mg twice daily (total daily dose 200 mg) throughout the entire treatment period (17 weeks). Used only in the BZMD experimental arm as part of the 4-month short-course regimen for drug-susceptible tuberculosis treatment.

Isoniazid tablets administered orally at 300 mg once daily in the morning throughout the entire treatment period. Used in the BZMH experimental arm (17 weeks) and in the standard control group (26 weeks) as part of tuberculosis treatment regimens.

Rifampicin tablets administered orally once daily in the morning throughout the entire treatment period (26 weeks). Dosing by weight: 450 mg for 40.0-49.9 kg, 600 mg for 50.0-70.9 kg and ≥75.0 kg. Used only in the standard control group as part of the 6-month standard tuberculosis treatment regimen.

Ethambutol tablets administered orally during the intensive phase (8 weeks). Dosing by weight: 750 mg for 40.0-49.9 kg, 1000 mg for 50.0-70.9 kg and ≥75.0 kg. Used only in the standard control group as part of the 6-month standard tuberculosis treatment regimen.