Status:
RECRUITING
A PAN-USR TB Multi-Center Trial
Lead Sponsor:
Shenzhen Third People's Hospital
Collaborating Sponsors:
First Affiliated Hospital of Zhejiang University
Beijing Chest Hospital of Capital Medical University
Conditions:
Pulmonary Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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, rankin...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age range from 18 to 65 years old, regardless of gender;
- Clinical symptoms and/or pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis;
- Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, whether resistant to rifampicin or not; Recommend using respiratory specimens for GeneXpert MTB/RIF testing;
- Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits;
- Willing to undergo HIV testing;
- Willing to preserve samples including DNA;
- For women with fertility, they have a negative serum or urine pregnancy test within 3 days before enroll the study and be willing to use effective contraceptive measures during the study period. Female subjects without fertility must have records of menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. Acceptable forms of contraception include condoms, intrauterine devices, cervical caps with spermicides, and diaphragm with spermicides.
- Exclusion criteria:
- Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including first-line and second-line anti-tuberculosis drugs);
- Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones \[including moxifloxacin, sitagliptin\], pyrazinamide);
- Resistance to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones \[including moxifloxacin, sitagliptin\], pyrazinamide). The following detection methods can be used: tNGS or other drug sensitivity testing methods (such as GeneXpert MTB/XDR, dissolution curve method, phenotypic drug sensitivity, etc.);
- Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary tuberculosis + tuberculous pleurisy/bronchial tuberculosis/mediastinal lymph node tuberculosis. Extrapulmonary tuberculosis refers to tuberculosis other than the chest-related types mentioned above);
- Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;
- Simultaneously using drugs that affect the efficacy of this study or have contraindications for combination therapy;
- Use of any immunosuppressive medication or systemic glucocorticoids for more than 2 weeks before screening;
- Any medication currently used or planned to be used that is known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole, itraconazole, procaine, quinidine, or sotalol;
- Uncontrolled blood sugar in diabetes, with no likelihood of improving blood sugar status according to the judgment of the researchers;
- HIV positive;
- Coexisting with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, or malignant tumors;
- Laboratory parameters within 14 days prior to recruitment: (1) Serum AST and ALT levels ≥ 3 times the upper limit of normal (ULN); (2) Blood creatinine ≥ 2 times ULN; (3) Hemoglobin ≤ 70 g/L; (4) Platelet count ≤ 50 × 10\^9/L; (5) Blood potassium levels are ≥ 5.5 mmol/L or ≤ 3.5 mmol/L;
- ECG QTcF ≥450 ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); Presence of one or more risk factors that could cause QT interval prolongation, such as arrhythmia, myocardial ischemia, etc.; history or family history of long QT syndrome;
- Women who are pregnant or breastfeeding;
- Weight \<30 kg, or ≥90 kg;
- The patient has participated in clinical trials of other drugs within the past 3 months during the screening period;
- Other conditions deemed unsuitable for participation in the study by the research doctors.
Exclusion
Key Trial Info
Start Date :
June 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT06905522
Start Date
June 18 2025
End Date
December 1 2029
Last Update
December 1 2025
Active Locations (3)
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1
Beijing Chest Hospital of Capital Medical University
Beijing, China
2
Shenzhen Third People's Hospital
Shenzhen, China
3
The Sixth People's Hospital of the Xinjiang Uygur Autonomous Region
Ürümqi, China