multidrug-resistant tuberculosis
Conditions
Interventions
discontinued group:withdrawing the drugs at month 6
continued group:continuing the drugs to 9 months
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
13 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily take the test object and sign the informed consent or parental/guardian permission is provided (informed consent) for patients under 18 years old. 2. Between the ages of 13 and 75, male or female; 3. Diagnosis of rifampin-resistant tuberculosis or MDR-TB by GeneXpert; 4. Positive culture of Mycobacterium tuberculosis or positive AFB staining of Mycobacterium tuberculosis in the sputum within three months before enrollment; 5. No second-line anti-tuberculosis drugs have been used, or have been used for more than six months but treatment failed, or changed more than one drug due to side effects or intolerance; 6. Chest radiography or CT confirmed pulmonary tuberculosis, with or without pulmonary cavity; 7. Women of childbearing age have a negative pregnancy urine test and agree to use high-efficiency contraception during the study period, either during pregnancy or during lactation.
Exclusion criteria
Exclusion criteria: 1. Before starting treatment, existed resistance to fluoroquinolones, bedaquinoline, linezolid, or cycloserine by rapid molecular biology methods, in vitro drug susceptibility tests, whole-genome sequencing methods, or GeneXpert XDR; 2. Allergy or intolerant to these drugs: bedaquinoline, linezolid, fluoroquinolones, cycloserine; 3. Using drugs that affect the observation of the curative effect of this study (glucocorticoids, interferon); drugs that are contraindicated with the drugs in this study, including non-steroidal anti-inflammatory drugs, monoamine oxidase inhibitors (phenelzine, isocarb Hydrazine, etc.); direct or indirect sympathomimetic drugs (such as pseudoephedrine); vasopressor drugs (such as epinephrine, norepinephrine); dopamine drugs (such as dopamine, dobutamine); serotonin Reuptake inhibitors; tricyclic antidepressants; serotonin 5-HTI receptor antagonists (amitriptyline); pethidine or buspirone, etc.; 4. Hemoglobin less than 90g/L or platelets less than 75*10^9/L; Impaired renal function (serum creatinine exceeds 1.5 times the upper limit of normal), or impaired liver function (ALT and / or AST levels are three times the upper limit of laboratory reference values); 5. Diabetic patients with poor blood sugar control (HBAc1 > 7.0%) and no desire to improve; 6. Significant ECG abnormality (QT interval prolonged by more than 450 ms); 7. HIV positive or AIDS patients; 8. According to the judgment of the research physician, Severely ill patients who is impossible to survive more than 4 months; 9. Karnofsky score < 50%; 10. Pregnant; 11. According to the judgment of the researchers, the subject has any disease that is not suitable for participating in this topic or may prevent the patient from participating in the whole process of this topic (such as having 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; severe mental illness, alcoholism, drug addiction or other related serious diseases that affect treatment Including immunodeficiency); 12. Extrapulmonary tuberculosis; 13. Those who participated in any other clinical trials within three months before the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unfavorable outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| culture conversion at month 2 and 6;The incidence, frequency, duration, severity and prognosis of serious adverse events and pre-defined adverse events of special concern that can lead to changes in the treatment of tuberculosis (QT prolongation, peripheral neuropathy, optic neuritis, bone marrow suppression, lactic acid Poisoning and serotonin syndrome, etc.);treatment response at 6 month; | — |
Countries
China
Contacts
Public ContactDeng Guofang
Shenzhen Third People's Hospital
Outcome results
None listed