Tuberculosis
Conditions
Interventions
One:3 Z Am Mfx+XY/3Z Am3 Mfx + XY /18Z Mfx+ XY
Two:Group A: 3 Rfb Z Am Mfx+XY /3 RfbZ Am3 Mfx+XY/12RfbZ Mfx+XY Group B: 3 ClrZ Am Mfx+XY /3 Clr Z Am3 Mfx+XY/12Clr Z Mfx+XY
Three:3 Z Am Lfx+XY /3Z Am3 Lfx+XY/18Z Lfx+XY
Sponsors
Beijing Chest Hospital,Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary to subjects,agree to sign the consent form; 2. Age between 18-65,female and male,including inpatient and outpatient; 3. Clinical diagnosised to MDR-TB (sputum mycobacterium tuberculosis culture positive, Strain identification except for non-tuberculous mycobacteria, and two or more anti-TB drug resistance); 4. Chest X-ray examination results confirmed tuberculosis, there are lung lesions, with or without holes; 5. Enrolled within the first 4 months,sputum mycobacterium tuberculosis culture positive or sputum smear AFB staining positive for M. tuberculosis; 6. Negative urine pregnancy women of childbearing age and agree to use effective contraception during the study period 7. Disease duration<=3 years,there are four kinds of sensitive drug composition optionally chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Have allergy history to study drug or any ingredient of it; 2. There are serious complications or impaired renal function (serum creatinine levels, ALT and / or AST levels greater than 1.2 times the upper limit of the laboratory reference value); 3. Clinically significant ECG abnormalities (QT interval over 430 milliseconds extended male patients, female patients with prolonged QT interval over 450 milliseconds); 4. History of cardiovascular disease or are suffering from such diseases, such as heart failure, hypertension (blood pressure poorly controlled), arrhythmias or myocardial infarction state; 5. Pregnant or lactating women; 6. Karnofsky score<50%; 7. In preclinical studies within three months who are participated in any other clinical trials; 8. According to the research group judgment, the subject is suffering not suitable to participate in this project or may make patients unable to participate in this project the whole process of any diseases (such as: severe mental illness or other effects related to the treatment of serious diseases (such as pneumoconiosis, etc.); 9. HIV antibody-positive and AIDS patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| empty; | — |
Countries
China
Contacts
Public ContactLi Qi
Outcome results
None listed