multidrug-resistant tuberculosis
Conditions
Interventions
A:BdqLzdFQCsZ
B:LzdFQCsCfzZ
C:BdqLzdCsCfzZ
D:LzdCsCfzZ+ SASP
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteers who are willing to sign informed consent; 2. The age is between 5-75 years old, male and female are unlimited, including inpatients and outpatients; 3. Rifampin resistant TB patients were confirmed by molecular biological methods, including rifampin resistant TB, MDR TB (resistant to isoniazid and rifampin at the same time), XDR TB (resistant to fluoroquinolones or second-line injections) and quasi XDR TB (resistant to fluoroquinolones and second-line injections at the same time); 4. The patients with positive culture of Mycobacterium tuberculosis in sputum or positive staining of Mycobacterium tuberculosis in sputum smear within 3 months before admission; 5. Patients who have not used second-line antituberculosis drugs, or used second-line antituberculosis drugs for less than 2 months, or used second-line antituberculosis drugs for more than 6 months but failed in treatment; 6. Patients with pulmonary tuberculosis confirmed by chest film or CT, with or without pulmonary cavity, with or without extrapulmonary tuberculosis; 7. Pregnant women of childbearing age have negative urine test and agree to use effective contraceptive measures during the study period, or pregnant women, or lactating women.
Exclusion criteria
Exclusion criteria: 1. Patients with impaired renal function (serum creatinine 1.5 times higher than the upper limit of normal), or impaired liver function (ALT and / or AST levels 3 times higher than the upper limit of laboratory reference value); 2. Diabetic patients with poor blood glucose control (HbAc1 > 7.0%) and no intention to improve; 3. Patients with significant ECG abnormalities (QT interval prolongation over 450 ms); 4. Patients who have a history of cardiovascular disease or are suffering from such diseases as heart failure, hypertension (poor blood pressure control), arrhythmia or post myocardial infarction status; 5. HIV positive or AIDS patients; 6. Patients with Karnofsky score less than 50%; 7. According to the judgment of the research group, patients with any disease (such as serious mental illness, alcohol, drug abuse or other related serious diseases affecting treatment, including immune deficiency) that are not suitable for the research or may make the patients unable to participate in the whole process of the research; 8. Patients who have participated in any other clinical trial within 3 months before the clinical study. 9. Patients with malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients who achieved favorable outcomes which including cured and treatment completed;incidence and outcome, the frequency of, time to and severity grade of SAEs and pre-defined adverse events of special interest (QT prolongation, peripheral neuropathy, optic neuritis, myelosuppression, lactic acidosis, and serotonin syndrome, hearing loss, acute renal failure, hypokalemia, hypomagnesemia, hepatotoxicity, etc..; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of and time to relapse, Frequency of conversion after two-mon, six-mon after initiation of treatment, Medium time to culture reversion before initial conversion, Frequency of recurrence-free survival which was confirmed by absence of radiological, clinical or bacteriological signs of TB at the 24-month post-treat;Treatment interrupted which defined as participants who stopped taking linezolid or bedaquiline for one month or longer at any point in the course of treatment.; | — |
Countries
China
Contacts
Public ContactDeng Guofang
Shenzhen Third People's Hospital
Outcome results
None listed