Multi-drug resistant tuberculosis
Conditions
Interventions
treatment group:12Bdq.Lzd.Cs.PZA.Pto
controlled group:6Cm Lzd. Cs.PZA.Pto/14 Lzd. Cs.PZA.Pto
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-65 (including 18 and 65 years old); 2. Tuberculosis patients with sputum Mycobacterium tuberculosis culture positive, and traditional drug sensitivity results showed that they were at least resistant to isoniazid, rifampicin and fluoroquinolones, while xpert MTB / RIF molecular detection showed that they were resistant to RFP; 3. Subjects with no previous medication history or previous second-line treatment history less than 1 month; 4. Those subjects who are willing to enter the study with informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with diabetes, HIV positive, long-term use of immunosuppressants, combined with immune dysfunction and other diseases; 2. Patients with lung malignant tumor, silicosis, non tuberculosis mycobacterium tuberculosis, severe extrapulmonary tuberculosis and bronchial tuberculosis; 3. Pregnant women, children, teenagers, the elderly and other special groups; 4. Subjects who have allergic history or contraindications to any of the six drugs in the protocol and can't use any of the drugs in the protocol; or those who can't insist on using injection drugs; those who are resistant to any one of the drugs in the treatment protocol according to the traditional drug sensitivity results; 5. Subjects who were identified as nontuberculous Mycobacterium tuberculosis by strain identification; 6. Subjects with severe hepatic and renal insufficiency, chronic active hepatitis, and mental illness were unable to use the relevant drugs in the protocol; 7. Patients with organic heart disease, QT interval more than 500ms, can not adhere to the use of any drug in the program; 8. The patients who are in critical condition and the researchers judge that survival is not suitable for clinical trials; 9. Subjects who are participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment success rate; | — |
Countries
China
Contacts
Public ContactLin Fan
Shanghai Pulmonary Hospital
Outcome results
None listed