Rifampicin-resistant/multidrug resistant tuberculosis
Conditions
Interventions
Experimental group A:4-6 BDQ- Mfx-Pto-LZD-PZA-hINH-EMB/5 Mfx-LZD-PZA-EMB
Experimental group B:4-6 Am-Mfx-Pto-LZD-PZA-hINH-EMB/5 Mfx-LZD-PZA-EMB
Control group:6 LZD- Mfx-Cfz-Cs-Z(Pto/E)/12-14 Mfx-Cfz-Cs-Z(Pto/E)
Sponsors
Xi'an Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-65 years (including those aged 18 and 65); 2. Newly diagnosed patients with rifampicin-resistant/MDR-TB will be enrolled in the study with molecular biology Rapid drug sensitivity Test (DST) or phenotypic drug sensitivity test; 3. No anti-TB drugs have been used, or anti-TB drugs have been used for less than 1 month; 4. Informed consent and willingness to enter the study; 5. Chest CT examination results confirmed pulmonary tuberculosis, with or without pulmonary cavity lesions; 6. Premenopausal women had a negative pregnancy urine test and agreed to use highly effective contraception during the study.
Exclusion criteria
Exclusion criteria: 1. Patients with HIV positive, long-term use of immunosuppressants, abnormal immune function and other diseases; 2. Complicated with pulmonary malignant tumor, silicosis, non-tuberculous mycobacterium lung disease, severe extrapulmonary tuberculosis and severe bronchial tuberculosis; 3. Pregnant or nursing patients and other special groups; 4. Those who are allergic to any of the drugs in the short-range regimen or have contraindications that prevent them from using any of the drugs in the regimen; The results of drug sensitivity indicated that patients with resistance to fluoroquinolones and second-line injectable drugs (patients with resistance to isoniazid need not be excluded); 5. Patients with severe liver and kidney dysfunction, chronic active hepatitis, or mental illness who are unable to use relevant drugs in the program; 6. Patients with organic heart disease, QT interval of more than 450ms, unable to adhere to any drug in the program; 7. Those who are participating in another clinical trial; 8. Patients with hemoglobin less than 90g/L or platelets less than 50x10^9/L; 9. Have a history of epilepsy, major depression, irritability or mental illness’’; 10. Patients considered by the researchers to be ineligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acid-fast bacillus test of sputum smear;Culture of mycobacterium tuberculosis in sputum;Chest computed tomography (CT);Drug sensitive test; | — |
Countries
China
Contacts
Public ContactRen Fei
Xi'an Chest Hospital
Outcome results
None listed