Tuberculosis
Conditions
Interventions
Case series:linezolid-containing MDR-TB regimens
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
5 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer as a participant who signed an informed consent; 2. Aged between 5 and 75 years old, male or female, including inpatient and outpatients; 3. TB patients with rifampicin-resistance confirmed by molecular biology methods, with or without aminoglycoside and / or fluoroquinolone resistance; 4. In three months before enrollment, M. tuberculosis culture positive or sputum smear AFB staining for M. tuberculosis positive; 5. MDR-TB patients who have not used second-line anti-tuberculosis drugs, or for less than two months, or for more than 6 months but treatment fails; 6. Tuberculosis with intrapulmonary lesions, with or without cavities, with or without extrapulmonary tuberculosis 7. Women of childbearing age with a negative pregnancy urine test and willing to use high-efficiency contraception during the study period, or pregnant women, or lactating women.
Exclusion criteria
Exclusion criteria: 1. Impaired renal function (serum creatinine level 1.5 times the laboratory reference limit) or impaired liver function (ALT and / or AST level 2.5 times the laboratory reference limit); 3. diabetic patients with high blood glucose (HBAc1> 7.0%) and no will to make efferts to control it; 4. Significant ECG abnormalities (the QT interval more than 430 milliseconds for male and more than 450 milliseconds for female); 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. HIV positive or AIDS patients; 7. Karnofsky score <50% (see Annex 1); 8. Juged by the research team, the subject has any disease that is not suitable for participating in the subject or may prevent the patient from maintaining in the whole process of the study, such as severe mental illness, alcoholism, drug use, or other serious illnesses affecting treatment, including immunodeficiency; 9. participated in any other clinical trials within 3 months prior to clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cured and treatment completed (favorable outcomes);Treatment failed, lost to follow-up, died (unfavorable outcomes);Incidence and outcome of clinically relevant AEs;AEs attributed to linezolid (peripheral and optic neuropathy, anemia, thrombocytopenia, lactic acidosis, and serotonin syndrome);Frequency of, time to and severity grade of clinically relevant AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of and time to relapse;Frequency of conversion during two months after initiation of treatment with linezolid;Frequency of conversion during six months after initiation of treatment with linezolid;Frequency of and time to culture reversion before initial conversion;Frequency of recurrence-free survival (confirmed absence of radiological, clinical or bacteriological signs of TB at the 24-month post-treatment follow-up visit); | — |
Countries
China
Contacts
Public ContactFu Liang
Shenzhen Third People's Hospital
Outcome results
None listed