\# Brief Summary
This study aims to evaluate the early bactericidal activity (EBA), safety, and tolerability of 4-month short-course regimens containing bedaquiline, moxifloxacin, and pyrazinamide in patients with drug-susceptible tuberculosis. This is a prospective, randomized, controlled, multicenter study planned to enroll 45 rifampicin-susceptible tuberculosis patients, who will be randomized in a 1:1:1 ratio to the BZMD group (bedaquiline + pyrazinamide + moxifloxacin + delamanid), BZMH group (bedaquiline + pyrazinamide + moxifloxacin + isoniazid), and standard control group. Subjects in the test groups will receive 17 weeks (4 months) of group-specific treatment regimens, while subjects in the control group will receive 26 weeks (6 months) of standard HRZE regimen treatment.
The primary endpoint is the change from baseline in log₁₀ colony-forming units (CFU) per milliliter of sputum specimen from Day 0 (pre-dose) to Day 14 of treatment (EBA CFU₀-₁₄), used to evaluate the early bactericidal activity of the drugs. Secondary endpoints include EBA CFU and EBA TTP (time to positive culture) at other time intervals, pharmacokinetic characteristics, sustained microbiological clearance rates, relapse rates, and safety indicators. The study will analyze the daily decline in log₁₀ CFU counts and daily increase in TTP using nonlinear mixed-effects models to reflect the bactericidal activity of the study regimens.
This study will help provide more effective and safer short-course treatment options for Chinese patients with drug-susceptible tuberculosis, thereby improving treatment adherence and treatment success rates, and providing scientific evidence for optimizing short-course treatment regimens for drug-susceptible tuberculosis.
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
Evidence of concurrent extrapulmonary TB
Subjects who have participated in other clinical studies within 8 weeks before the screening period
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
Parallel
Bedaquiline (B)
DrugBedaquiline 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
DrugMoxifloxacin 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 (PZA)
DrugPyrazinamide 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 (D)
DrugDelamanid 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 (H)
DrugIsoniazid 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 (R)
DrugRifampicin 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 (E)
DrugEthambutol 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.
Early Bactericidal Activity CFU 0-14 (EBA CFU₀-₁₄)
The change from baseline in log10 colony-forming units (CFU) per milliliter of sputum specimen from baseline (Day 0, pre-dose) to Day 14 of treatment. This measures the early bactericidal activity of the drug regimens over the first 14 days of treatment.
Early Bactericidal Activity CFU 0-2 (EBA CFU₀-₂)
The change from baseline in log10 CFU per milliliter of sputum specimen from baseline to Day 2 of treatment.
Early Bactericidal Activity CFU 0-7 (EBA CFU₀-₇)
The change from baseline in log10 CFU per milliliter of sputum specimen from baseline to Day 7 of treatment.
Early Bactericidal Activity TTP 0-14 (EBA TTP₀-₁₄)
The daily change from baseline in time to positive culture (TTP, in hours) from baseline (Day 0, pre-dose) to Day 14 of treatment. This measures the early bactericidal activity by evaluating the extension in time required for bacterial culture to become positive.
Sustained Microbiological Clearance Rate
The sustained microbiological clearance rate at the end of 17 weeks of treatment in the test groups and control group. Defined as at least two consecutive negative culture results from respiratory specimens after baseline, with an interval of ≥14 days between specimen collection dates.
Early Bactericidal Activity CFU 7-14 (EBA CFU₇-₁₄)
The change from baseline in log10 colony-forming units (CFU) per milliliter of sputum specimen from Day 7 to Day 14 of treatment. This measures the bactericidal activity during the second week of treatment.
Early Bactericidal Activity TTP 0-2 (EBA TTP₀-₂)
The daily change from baseline in time to positive culture (TTP, in hours) from baseline (Day 0, pre-dose) to Day 2 of treatment. This measures the very early bactericidal activity within the first 2 days of treatment.
Early Bactericidal Activity TTP 0-7 (EBA TTP₀-₇)
The daily change from baseline in time to positive culture (TTP, in hours) from baseline (Day 0, pre-dose) to Day 7 of treatment. This measures the early bactericidal activity during the first week of treatment.
Early Bactericidal Activity TTP 7-14 (EBA TTP₇-₁₄)
The daily change from baseline in time to positive culture (TTP, in hours) from Day 7 to Day 14 of treatment. This measures the bactericidal activity during the second week of treatment by evaluating changes in time to culture positivity.
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Shanghai Pulmonary Hospital, Shanghai, China
Lead sponsor
Huashan Hospital
Collaborator
Guangzhou National Laboratory
Collaborator
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