NCT06905522

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 610 (estimated)
• Sponsor: Shenzhen Third People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	Bedaquiline (B)	The initial dose of bedaquiline is 400 mg daily for 2 weeks, followed by 200 mg three times a week.
DRUG	Sitafloxacin (S)	200mg once daily
DRUG	Linezolid (L)	600mg once daily
DRUG	Pyrazinamide (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.
DRUG	Isoniazid (H)	4-6 mg/kg once daily, 300 mg once daily
DRUG	Rifampicin (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.
DRUG	Ethambutol (E)	15-25 mg/kg once daily, 750 mg once daily
DRUG	Moxifloxacin (M)	400mg once daily
DRUG	Pretomanid (Pa)	200mg once daily

Timeline

• Start date: 2025-06-18
• Primary completion: 2029-01-01
• Completion: 2029-12-01
• First posted: 2025-04-01
• Last updated: 2025-12-01

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated drug study