Tuberculosis
Conditions
Interventions
Group 1:6-8Cm Cfz CS Gfx Pto /6 Cfz CS GFX Pto
Group 2:6Cm Lfx CS Pto PZA/12 Lfx CS Pto PZA
Sponsors
Beijing Chest Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteer as a subject and sign an informed consent form; 2. Aged between 18 and 65 years old, male or female, including inpatient and outpatients; 3. MDA-TB patients with isoniazid and rifampicin-resistant were screened by molecular biology methods. 4. have not used second-line anti-tuberculosis drugs, or second-line anti-tuberculosis drugs used less than 6 months. 5. Modified Roche culture susceptibility test results confirmed as MDR-TB patients, excluding aminoglycoside and / or fluoroquinolone resistance, ie, XDR-TB and quasi-XDR-TB -XDR-TB). 6. Clinical diagnosis of multidrug-resistant tuberculosis (MDR-TB): MDR-TB: positive for culture of tubercle bacilli, except for non-tuberculous mycobacteria identified by strains, and resistant to more than two anti-tuberculosis drugs (including at least H, R). 7. chest X-ray examination confirmed tuberculosis, with intrapulmonary lesions, with or without cavities; 8. In the first 4 months before enrollment, M. tuberculosis culture positive or sputum smear AFB staining for M. tuberculosis was positive; 9. Women of childbearing age have a negative pregnancy urine test and agree to use high-efficiency contraception during the study period.
Exclusion criteria
Exclusion criteria: 1. A person with a history of allergies to the study drug or any of its ingredients; 2. Currently there is severe comorbidity or impaired renal function (serum creatinine level = 265umol/L) or impaired liver function (ALT and / or AST level 2.5 times the laboratory reference limit; 3. diabetic patients; 4. There are significant ECG abnormalities in the clinic (the QT interval of male patients is extended by more than 430 milliseconds, and the QT interval of female patients is extended by more than 450 milliseconds); 5. have a history of cardiovascular disease or are suffering from such diseases, such as heart failure, high blood pressure (poor blood pressure control), arrhythmia or post-myocardial infarction state; 6. pregnant or lactating women; 7. Karnofsky score <50% (see Annex 1); 8. participated in any other clinical trials within 3 months prior to clinical study; 9. According to the research team, the subject has any disease that is not suitable for participating in the subject or may prevent the patient from participating in the whole process of the subject (such as: serious mental illness or other serious diseases affecting treatment (such as pneumoconiosis); 10. HIV positive or AIDS patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of conversion at the end of the course of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of adverse reactions;The rate of Treatment failure; | — |
Countries
China
Contacts
Public ContactChu Naihui
Beijing Chest Hospital affiliated to Capital Medical University
Outcome results
None listed