Overview

A PAN-USR TB Multi-Center Trial

Status:
NOT_YET_RECRUITING
Trial end date:
2029-12-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE3
Details
Lead Sponsor:
Shenzhen Third People's Hospital
Collaborators:
Beijing Chest Hospital of Capital Medical University
First Affiliated Hospital of Zhejiang University
Guizhou Aerospace Hospital
Shenyang Tenth People's Hospital
The Fourth Hospital of Inner Mongolia Autonomous Region
The Sixth People's Hospital of the Xinjiang Uygur Autonomous Region
Treatments:
bedaquiline
Ethambutol
Isoniazid
Linezolid
Moxifloxacin
pretomanid
Protons
Pyrazinamide
Rifampin
sitafloxacin