Treatment Strategy for Rifampin-Susceptible Tuberculosis.
Nicholas I Paton, Christopher Cousins, Celina Suresh...
https://pubmed.ncbi.nlm.nih.gov/36808186Actively Recruiting
Phase 3
Age: 18Years - 65Years
All Genders
ID06905522
A Pan-Ultrashort Regimen for Drug-susceptible and Drug-resistant Pulmonary Tuberculosis: A Multi-Center Randomized Controlled Trial
Led by Shenzhen Third People's Hospital · Updated on 2025-12-01
610
Participants Needed
3
Research Sites
47 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
Pulmonary tuberculosis (TB) remains a major global health challenge, especially in China, which has a high burden of both drug-susceptible and drug-resistant TB cases. Researchers are evaluating a new ultra-short-course treatment regimen called PAN-TB that aims to be effective for all active TB types. This regimen seeks to simplify treatment, reduce costs, shorten treatment duration to 2-3 months, and improve safety and success rates compared to standard care. The study compares multiple treatment regimens including a 2-month bedaquiline, linezolid, sitafloxacin, and pyrazinamide (BLSZ) regimen with possible extensions up to 13 weeks, a standard 6-month regimen using isoniazid, rifampicin, pyrazinamide, and ethambutol, and a 6-month bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM) regimen with potential extension to 9 months if needed. Each treatment arm is tailored for either drug-susceptible or drug-resistant TB, and adjustments are made based on sputum smear or culture results and clinical symptoms. Participants will undergo regular follow-up visits for up to 18 months to monitor treatment outcomes and safety. Assessments include sputum culture conversion, clinical symptom evaluation, chest imaging, laboratory tests, and adverse event monitoring. The primary outcomes focus on unfavorable outcomes at 12 months and safety at 2 months, with additional secondary outcomes tracking longer-term treatment success and side effects. The study also aims to identify new biomarkers linked to treatment responses throughout the therapy.
CONDITIONS
Brief Title
A PAN-USR TB Multi-Center Trial
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, any gender
- Clinical symptoms and/or chest imaging support active pulmonary tuberculosis diagnosis
- Confirmed presence of Mycobacterium tuberculosis by microbiological testing, with or without rifampicin resistance
- Willing and able to provide informed consent and comply with follow-up visits
- Agree to HIV testing
- Agree to preserve biological samples including DNA
- Women of childbearing potential must have a negative pregnancy test within 3 days before enrollment and use effective contraception during the study; women without fertility must have documented menopause or sterilization
You will not qualify if you...
- Previous treatment for active pulmonary tuberculosis including first- or second-line drugs
- Allergy or intolerance to study drugs like bedaquiline, linezolid, fluoroquinolones, or pyrazinamide
- Resistance to any study drug confirmed by drug sensitivity tests
- Having hematogenous disseminated tuberculosis or extrapulmonary tuberculosis outside the chest
- Presence of non-tuberculous mycobacteria or other lung infections affecting treatment
- Use of drugs interfering with study treatment or contraindications for combination therapy
- Use of immunosuppressive medications or systemic glucocorticoids for over 2 weeks before screening
- Use of medications known to prolong QTc interval
- Poorly controlled diabetes not expected to improve
- HIV positive status
- Severe autoimmune diseases, severe liver/kidney dysfunction, psychiatric disorders, blood disorders, or cancer
- Abnormal lab values such as elevated liver enzymes, creatinine, low hemoglobin or platelets, or abnormal potassium
- Prolonged QTc interval or risk factors for QT prolongation
- Pregnant or breastfeeding women
- Weight under 30 kg or over 90 kg
- Participation in other drug trials within past 3 months
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 9 to 26 weeks depending on regimen and response, with possible extensions up to 13 or 39 weeks
Participants receive drug regimens specific to their tuberculosis type. Drug-susceptible TB participants receive either a 9-week regimen of bedaquiline, linezolid, sitafloxacin, and pyrazinamide (extendable to 13 weeks if needed) or a 26-week regimen starting with isoniazid, rifampicin, pyrazinamide, and ethambutol followed by isoniazid and rifampicin. Drug-resistant TB participants receive either the same 9 to 13-week bedaquiline-based regimen or a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin, extendable to 9 months if conditions do not improve.
Weekly or periodic visits during treatment depending on regimen and clinical status
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
Loading map...
Research Team
P
Professor Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Bedaquiline-Pretomanid-Linezolid Regimens for Drug-Resistant Tuberculosis.
Francesca Conradie, Tatevik R Bagdasaryan, Sergey Borisov...
https://pubmed.ncbi.nlm.nih.gov/36053506A 24-Week, All-Oral Regimen for Rifampin-Resistant Tuberculosis.
Bern-Thomas Nyang'wa, Catherine Berry, Emil Kazounis...
https://pubmed.ncbi.nlm.nih.gov/36546625Short oral regimens for pulmonary rifampicin-resistant tuberculosis (TB-PRACTECAL): an open-label, randomised, controlled, phase 2B-3, multi-arm, multicentre, non-inferiority trial.
Bern-Thomas Nyang'wa, Catherine Berry, Emil Kazounis...
https://pubmed.ncbi.nlm.nih.gov/37980911Mechanisms of Pyrazinamide Action and Resistance.
Ying Zhang, Wanliang Shi, Wenhong Zhang...
https://pubmed.ncbi.nlm.nih.gov/26104205'Z(S)-MDR-TB' versus 'Z(R)-MDR-TB': improving treatment of MDR-TB by identifying pyrazinamide susceptibility.
Ying Zhang, Kwok Chiu Chang, Chi-Chiu Leung...
https://pubmed.ncbi.nlm.nih.gov/26038418Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study.
Liang Fu, Xilin Zhang, Juan Xiong...
https://pubmed.ncbi.nlm.nih.gov/37567554