Tuberculosis (TB) remains a major public health issue and one of the top ten causes of death from a single infectious disease worldwide. China is among the countries with the highest TB burden, ranking third globally for total TB cases and second for drug-resistant TB cases. PAN-TB is an innovative concept in TB treatment, aiming to develop a universal regimen effective for all forms of active TB, including both drug-susceptible and drug-resistant strains. The primary goal of the PAN-TB regimen is to simplify the treatment process, reduce costs, and improve treatment success rates. The ideal Target Regimen Profile (TRP) for PAN-TB includes superior efficacy compared to standard treatment for non-drug-resistant TB, a reduced treatment duration from the current 4-6 months to 2-3 months, and improved safety and tolerability. This project aims to explore a new ultra-short-course treatment regimen for both drug-sensitive (DS-TB) and drug-resistant TB (MDR/RR-TB), which aligns with the latest trends in TB treatment both domestically and internationally. The regimen also has significant practical implications for enhancing treatment efficacy and reducing patient burden. Furthermore, the study will explore the identification of new biomarkers closely linked to treatment outcomes over the course of full-cycle therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
610
The initial dose of bedaquiline is 400 mg daily for 2 weeks, followed by 200 mg three times a week.
200mg once daily
600mg once daily
20-30 mg/kg/day; 1000 mg for patients weighing \<50 kg, 1500 mg for patients weighing ≥50 kg but \<75 kg, and 2000 mg for patients weighing ≥75 kg.
4-6 mg/kg once daily, 300 mg once daily
8-12 mg/kg once daily, 450 mg for patients weighing \<50 kg, 600 mg for patients weighing ≥50 kg but \<75 kg, and 750 mg for patients weighing ≥75 kg.
15-25 mg/kg once daily, 750 mg once daily
400mg once daily
200mg once daily
Beijing Chest Hospital of Capital Medical University
Beijing, China
RECRUITINGShenzhen Third People's Hospital
Shenzhen, China
RECRUITINGThe Sixth People's Hospital of the Xinjiang Uygur Autonomous Region
Ürümqi, China
RECRUITINGUnfavorable outcomes
Percentage of patients with unfavorable outcomes (failure, treatment interruption, death, loss to follow-up, re-treatment, recurrence) at 12 months (52 weeks) after randomization
Time frame: 12 months (52 weeks)
Safety
Percentage of patients who have treatment interruption due to any reason or died within 2 months (9 weeks) after randomization
Time frame: 2 months (9 weeks)
Sputum culture conversion rate
Time frame: 2 months (9 weeks) after randomization
Unfavorable outcomes (short-term)
Time frame: 6 months (26 weeks) after randomization
Unfavorable outcomes (mid-term)
Time frame: 18 months (78 weeks) after randomization
Time to sputum culture conversion
Time frame: Median time
Serious adverse events or grade 3 or higher adverse events (short-term)
Time frame: 12 months (52 weeks) after randomization
Serious adverse events or grade 3 or higher adverse events (mid-term)
Time frame: 18 months (78 weeks) after randomization
Adverse events during treatment
Time frame: 9 or 13 weeks (A1, A2); 26 weeks (B, C)
QTcF prolongation during treatment
Time frame: 9 or 13 weeks (A1, A2); 26 weeks (B, C)
Liver function damage during treatment
Time frame: 9 or 13 weeks (A1, A2); 26 weeks (B, C)
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