A PAN-USR TB Multi-Center Trial

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

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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University

  collaborator OTHER

• Beijing Chest Hospital of Capital Medical University

  collaborator UNKNOWN

• Shenyang Tenth People's Hospital

  collaborator OTHER

• The Sixth People's Hospital of the Xinjiang Uygur Autonomous Region

  collaborator UNKNOWN

• The Fourth Hospital of Inner Mongolia Autonomous Region

  collaborator UNKNOWN

• Guizhou Aerospace Hospital

  collaborator UNKNOWN

• Shenzhen Third People's Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-18

Primary Completion

2029-01-31

Completion

2029-12-31

FDA Drug

Yes

Countries

• China

Study Locations