Tuberculosis
Conditions
Interventions
MDR Experimental Group:3Am(Cm) Lfx Cfz + Z E PAS(Pto) / 3Am(Cm) Lfx Cfz + Z E PAS(Pto) /18 Lfx Cfz + Z E PAS(Pto)
MDR Control Group:3Am(Cm) Lfx+ Z E PAS(Pto) / 3Am(Cm) Lfx+ Z E PAS(Pto) /18 Lfx + Z E PAS(Pto)
XDR Experimental Group:6Cm Mfx (Gfx) Cfz Z E PAS(Pto)+two 4-5 group drugs/3-6 Cm3 Mfx (Gfx) Cfz Z E PAS(Pto)+two 4-5 group drugs/21-24 Mfx (Gfx) Cfz Z E PAS(Pto)+two 4-5 group drugs
XDR Control Group:6Cm Mfx (Gfx) Z E PAS(Pto)+two 4-5 group drugs/3-6 Cm3 Mfx (Gfx) Z E PAS(Pto)+two 4-5 group drugs/21-24 Mfx (Gfx) Z E PAS(Pto)+two 4-5 group drugs
Sponsors
Beijing Chest Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary to subjects,agree to sign the consent form; 2. Aged between 18-65 years female and male, including inpatient and outpatient; 3. Clinical diagnosised to MDR-TB or XDR-TB; 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. There are four kinds of sensitive drugs to choose from 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.).
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