Actively Recruiting
A PAN-USR TB Multi-Center Trial
Led by Shenzhen Third People's Hospital · Updated on 2025-12-01
610
Participants Needed
3
Research Sites
232 weeks
Total Duration
On this page
Sponsors
S
Shenzhen Third People's Hospital
Lead Sponsor
F
First Affiliated Hospital of Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A PAN-USR TB Multi-Center Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years, any gender
- Clinical symptoms or chest imaging supporting active pulmonary tuberculosis diagnosis
- Microbiological confirmation of Mycobacterium tuberculosis infection, with or without rifampicin resistance
- Voluntarily signed informed consent and willingness to attend follow-up visits
- Willingness to undergo HIV testing
- Agree to preserve samples including DNA
- Women of childbearing potential must have a negative pregnancy test within 3 days before enrollment and agree to use effective contraception during the study; women without fertility must have documented menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation
You will not qualify if you...
- Prior anti-tuberculosis treatment for active pulmonary TB
- Allergy or intolerance to study drugs including bedaquiline, linezolid, fluoroquinolones (moxifloxacin, sitafloxacin), or pyrazinamide
- Resistance to any study drug confirmed by drug sensitivity testing
- Hematogenous disseminated tuberculosis or extrapulmonary tuberculosis outside specified chest-related types
- Non-tuberculous mycobacterial or other lung infections affecting treatment
- Use of drugs that interfere with study drug efficacy or contraindicated combinations
- Use of immunosuppressive medications or systemic glucocorticoids for more than 2 weeks before screening
- Use of medications known to significantly prolong QTc interval
- Uncontrolled diabetes with no expected improvement
- HIV positive status
- Severe autoimmune, liver, kidney, psychiatric, hematological disorders, or cancer
- Abnormal lab tests within 14 days prior to recruitment: AST/ALT ≥ 3x upper limit, creatinine ≥ 2x upper limit, hemoglobin ≤ 70 g/L, platelet count ≤ 50 x 10^9/L, potassium outside 3.5-5.5 mmol/L
- ECG QTcF ≥ 450 ms or risk factors for QT prolongation
- Pregnant or breastfeeding women
- Weight less than 30 kg or 90 kg or more
- Participation in other drug clinical trials within past 3 months
- Any condition deemed unsuitable by study doctors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Beijing Chest Hospital of Capital Medical University
Beijing, China
Actively Recruiting
2
Shenzhen Third People's Hospital
Shenzhen, China
Actively Recruiting
3
The Sixth People's Hospital of the Xinjiang Uygur Autonomous Region
Ürümqi, China
Actively Recruiting
Research Team
P
Professor Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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