Pulmonary tuberculosis
Conditions
Interventions
Nidanib treatment group:Nintedanib combined with standard anti-tuberculosis treatment
Standard anti-tuberculosis treatment group:Standard anti-tuberculosis therapy, pyrimethamine rifa, isoniacin
Sponsors
Beijing Chest Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of pulmonary tuberculosis with positive acid-fast bacilli sputum smear and/or positive GeneXpert and/or culture results; 2. Chest imaging results consistent with the diagnosis of pulmonary tuberculosis with bilateral lung lesions and/or cavitation; 3. Must sign an informed consent form (ICF) indicating that they understand the purpose and prescribed procedures of this study and are willing to participate in the study, and are able to follow the contraindications and restrictions specified in this protocol; 4. At the time of informed consent, the age is 18 years old (inclusive) to 65 years old (inclusive), male or female; 5. Normal or abnormal physical examination and vital signs are judged by the doctor to be of no clinical significance.
Exclusion criteria
Exclusion criteria: 1. Resistance to rifampicin; 2. Severe extrapulmonary tuberculosis (hematogenous pulmonary tuberculosis, digestive system tuberculosis, genitourinary tuberculosis, osteoarticular tuberculosis, tuberculosis meningitis, etc.); 3. Those who have been treated with any drug that is effective against Mycobacterium tuberculosis within 3 months prior to screening; 4. Those with a history of specific allergies (asthma, eczema, etc.), or allergies, or known allergies to nintedanib or similars, such as immediate allergic reactions, angioedema, exfoliative dermatitis, urticaria or bronchial hypersensitivity reactions; History of hypersensitivity to rifampicin and derivatives, isoniazid, pyrazinamide or ethambutol; 5. Have a history of alcohol abuse [weekly alcohol intake greater than 21 units/week (males) and 14 units/week (females) (1 unit = 360mL beer; or 150mL of glucose wine; or 45mL of liquor)], or the subject is unwilling to stop drinking alcohol for the duration of the study; 6. Blood donation or significant blood loss (>450 mL) within 3 months prior to enrollment, or those who plan to donate blood or intend to undergo surgery during the study; 7. Suffering from any disease that increases the risk of bleeding; 8. Those who have participated in the clinical trial of any drug or medical device within 3 months before the use of the investigational drug, or are still in the follow-up period of a clinical study; 9. Clinically significant abnormalities in clinical laboratory examinations, or other clinical findings within 6 months prior to screening showing clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases); 10. History of invasive systemic fungal infection or other opportunistic infections within 2 months prior to screening; 11. Systemic or local infection within 2 months prior to screening, such as risk of sepsis and/or known active inflammation; 12. Those who have a history of drug abuse in the past five years or have used drugs in the 3 months before the trial; 13. Acute illness during the pre-study screening phase or prior to study administration; 14. Investigators, employees or related personnel of the research center; 15. Other factors that the investigator considers inappropriate to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median time to sputum culture conversion;Vital signs;Physical examination;Changes in clinical laboratory tests (complete blood count and blood biochemistry); | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-tuberculosis efficacy indicators;Pulmonary fibrosis and immune-related indicators; | — |
Countries
China
Contacts
Public ContactYu Lu
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed