Multidrug-resistant tuberculosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. voluntarily as the subject of the test, signed informed consent; 2. aged between 18-65 years (resistant to anti-tuberculosis drugs, the age may be appropriate to relax), men and women are not limited, including hospital and outpatients; 3. multidrug-resistant tuberculosis treatment failure, can not be in accordance with the standard anti-drug program anti-tuberculosis patients; 4. improved Roche culture drug susceptibility test results were diagnosed with MDR-PTB patients; 5. women of childbearing age pregnancy negative urine test and agreed to use during the study of effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1. With a history of allergy to the study drug or any of its ingredients; 2. To be currently associated with severe comorbidities or impaired renal function (serum creatinine levels =265 umol / L) or impaired liver function (ALT and / or AST levels 2.5 times the upper limit of laboratory reference); 3. patients with FQs, clinically significant ECG abnormalities (male patients QT interval prolonged more than 430 milliseconds, female patients QT interval extended more than 450 milliseconds); 4. 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; 5. pregnant or lactating women; 6. According to the task group to determine the subjects suffering from not suitable for participation in the subject or may make the patient can not participate in the whole process of any disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CT;Sputum culture; | — |
Secondary
| Measure | Time frame |
|---|---|
| T cell surgroup; | — |
Countries
China
Contacts
The Fifth People's Hospital of Suzhou