tuberculosis
Conditions
Interventions
FDC group (experimental group):Intensive phase (first 2 months): Oral administration of quadruple FDC (Ethambutol Pyrazinamide Rifampicin Isoniazid Tablets, containing HRZE) or triple FDC (Isoniazid R
Single-ingredient combination scheme group (control group):Intensive phase (first 2 months): Isoniazid, rifampicin, and pyrazinamide are taken orally once daily respectively, and whether to combine et
Sponsors
Beijing Chest Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be enrolled in the study: Newly treated pulmonary tuberculosis patients who meet the criteria for clinical diagnosis or confirmed diagnosis in the "2017 Diagnostic Criteria for Tuberculosis". Aged between 18 and 65 years old (inclusive of the boundary values), regardless of gender. Participants fully understand the study, voluntarily participate in it, and have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from enrollment: - Suffering from disseminated pulmonary tuberculosis or pulmonary tuberculosis with extensive lesions (defined as lesions involving more than 1/2 of the lung field or presence of lung lobe destruction). - Complicated with severe active extrapulmonary tuberculosis, such as craniocerebral tuberculosis, osteoarticular tuberculosis, tracheobronchial tuberculosis, abscess-type lymph node tuberculosis, genitourinary tuberculosis, tuberculous empyema, or encapsulated effusion, etc. - Having a known history of allergy or severe intolerance to any of the first-line anti-tuberculosis drugs involved in this study (isoniazid, rifampicin, pyrazinamide, ethambutol). - Confirmed resistance to isoniazid or rifampicin by genotypic or phenotypic drug susceptibility testing at baseline or after enrollment; or having a clear history of close contact with drug-resistant pulmonary tuberculosis patients or other high-risk factors for drug resistance, even without bacteriological evidence. - Female subjects who are pregnant, lactating, or planning to become pregnant during the study period. - Those with positive human immunodeficiency virus (HIV) antibodies. This exclusion is intended to avoid complex drug interactions between antiretroviral drugs and rifampicin (rifampicin is a strong inducer of hepatic cytochrome P450 enzymes), so as not to interfere with the evaluation of the efficacy and safety of any treatment regimen. - Having significant liver function abnormalities during the screening period, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN), or total bilirubin (TBIL) > ULN; or complicated with underlying liver diseases, including alcoholic liver disease, autoimmune liver disease, active chronic hepatitis, cirrhosis, etc. This exclusion is based on standard safety considerations that first-line anti-tuberculosis drugs (especially isoniazid, rifampicin, and pyrazinamide) all have potential hepatotoxicity. - Having renal insufficiency, defined as a creatinine clearance rate below 60 mL/min. This exclusion is intended to avoid the accumulation of drugs excreted through the kidneys (such as ethambutol and its metabolites) in the body, increasing the risk of toxicity. - Complicated with severe or uncontrolled diseases of other systems, such as cardiovascular diseases, cerebrovascular diseases, other respiratory diseases, mental diseases, gout, or severe diabetes (glycated hemoglobin > 8.5%). - Having a history of optic neuritis, color vision impairment, or being unable to cooperate with vision examinations. This is a specific exclusion criterion for the potential risk of optic nerve toxicity associated with ethambutol. - Currently participating in or planning to participate in any other interventional clinical trial within 4 weeks before screening. - In the investigator's clinical judgment, the subject has any other conditions that make them unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month treatment success rate: defined as the proportion of subjects who meet the criteria of "cured" or "completed treatment" at the end of the 6th month of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Long-term efficacy indicator: 24-month good outcome rate: the proportion of patients who achieved successful treatment at 6 months and had no recurrence during the subsequent follow-up up to 24 months.;Sputum culture conversion rate at various time points: the proportion of patients with positive baseline sputum bacteria whose sputum culture converted to negative at 2, 5, and 6 months of treatment.;Recurrence rate: The proportion of tuberculosis recurrence evaluated at the 12th-month and 24th-month follow-up points after successful treatment.; | — |
Countries
China
Contacts
Public ContactLi Liang; Yang Xinting
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed