RecruitingPhase 3NCT06905522

A PAN-USR TB Multi-Center Trial

A Pan-Ultrashort Regimen for Drug-susceptible and Drug-resistant Pulmonary Tuberculosis: A Multi-Center Randomized Controlled Trial

Sponsor

Shenzhen Third People's Hospital

Enrollment

610 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Tuberculosis

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bedaquiline (B), a drug called Ethambutol (E), and others for people with pulmonary tuberculosis. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBedaquiline (B)

The initial dose of bedaquiline is 400 mg daily for 2 weeks, followed by 200 mg three times a week.

DRUGSitafloxacin (S)

200mg once daily

DRUGLinezolid (L)

600mg once daily

DRUGPyrazinamide (Z)

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.

DRUGIsoniazid (H)

4-6 mg/kg once daily, 300 mg once daily

DRUGRifampicin (R)

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.

DRUGEthambutol (E)

15-25 mg/kg once daily, 750 mg once daily

DRUGMoxifloxacin (M)

400mg once daily

DRUGPretomanid (Pa)

200mg once daily