Tuberculosis
Conditions
Interventions
Short course group:3 Z Am Mfx+XY/3Z Am3 Mfx + XY /18Z Mfx+ XY
Long course group:3ZLfxAmXY/3ZLfxAm3XY /18ZLfxXY
control group:3ZCmLfxCsPto/3ZCm3Lfx CsPto/12ZLfxCsPto
Sponsors
Beijing Chest Hospital,Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary to be subjects and agree to sign the consent form; 2. Aged 18-65 years male and female, including inpatients and outpatients; 3. Clinical diagnosised MDR-TB (sputum mycobacterium tuberculosis culture positive, Strain identification with exclusion of non-tuberculous mycobacteria, with drug resistance to at least H and R); 4. Chest X-ray indicated tuberculosis with lung lesions, with or without cavity; 5. sputum mycobacterium tuberculosis culture positive or sputum smear AFB staining positive for M. tuberculosis within 4 month before enrollment initiation; 6. women at childbearing age present HCG negative and agree to use effective contraception during the study period; 7. Disease duration no more than 3 years, with four sensitive drugs to be selected for chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Allergy to study drug or any ingredient of it; 2. There are serious complications or impaired renal function (with serum creatinine levels, ALT and / or AST levels 1.2 times higher that the upper limit of the laboratory reference value); 3. Clinically significant ECG abnormalities (prolonged QT interval over 430 milliseconds for males and 450 milliseconds for females); 4. with history of cardiovascular disease or 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. be the subject of any other clinical trials within 3 month before enrollment initiation; 8. According to the research group judgment, the subject is not suitable to participate in this project for any sufferings or unable to participate the study due to diseases such as severe mental illness or other severe disease which may effect treatment outcome (such as pneumoconiosis, etc.); 9. HIV antibody-positive and AIDS patients.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| cavity size and number;lesion improvement; | — |
Primary
| Measure | Time frame |
|---|---|
| sputum smear conversion;sputum culture conversion; | — |
Countries
China
Contacts
Public ContactLi Qi
Beijing Chest Hospital, Capital Medical University /Beijing Tuberculosis and Thoracic Tumor Research Institute
Outcome results
None listed