Pulmonary Tuberculosis
Conditions
Interventions
Experimental Group:Based on the 6-month short-course standardized regimen for drug-resistant TB recommended in the WHO Guidelines on Tuberculosis Treatment (6BDLLfxC: BDLLfxC if fluoroquinolone resist
Control Group:Simplified 6-month short-course standardized treatment regimen recommended by WHO (6BDLLfxC):
BDLLfxC if fluoroquinolone resistance is unknown,
BDLLfx if susceptible to fluoroquinolones,
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 16 and 70 years old. 2. No gender restrictions. 3. Diagnosed with drug-resistant tuberculosis (DR-TB)—including RR-TB (rifampicin-resistant TB), MDR-TB (multidrug-resistant TB), or pre-XDR-TB (pre-extensively drug-resistant TB)—based on WHO guidelines. 4. HIV-negative. 5. Capable of understanding and signing informed consent.
Exclusion criteria
Exclusion criteria: 1. History of allergic reactions to any drugs used in the study protocol. 2. Concomitant severe medical conditions, including: Hepatic, renal, metabolic, or autoimmune disorders Neurological, psychiatric, or endocrine diseases Hematologic malignancies or active cancers Long-term use of immunosuppressive agents. 3. Pregnancy. 4. Deemed ineligible for participation after baseline evaluation. 5. Current enrollment in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sputum Acid-Fast Bacilli (AFB) Smear;Sputum Mycobacterium tuberculosis culture ;Early Bactericidal Activity (EBA) Test;Serial Sputum Colony Counting (SSCC);GYS-016 in peripheral blood plasma; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging examination;Clinical symptoms;iNOS in peripheral blood PBMCs; | — |
Countries
China
Contacts
Public ContactQin Sun
Shanghai Pulmonary Hospital
Outcome results
None listed