Rifampicin-resistant tuberculosis
Conditions
Interventions
intervention group:For patients who are sensitive to fluoroquinolones or whose drug sensitivity results are unknown, 6-9 months of treatment with bedaquiline (B), linezolid (L), and pautomycin (Pa) is
Sponsors
Beijing Chest Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this trial and sign the informed consent form; 2. Age between 14 and 65 years old, gender not restricted; 3. Patients with a body weight greater than 30 kilograms (wearing light clothing, without shoes); 4. Tuberculosis, with positive sputum culture within 1 month of the screening period or one smear test of 2+ or two smear tests of 1+ or more; 5. Molecular biology or phenotypic drug sensitivity test within 1 month of the screening period diagnosed rifampicin resistance; 6. Chest imaging examination results support the diagnosis of tuberculosis; 7. Pregnant women of childbearing age with negative urine pregnancy test and agree to use effective contraceptive measures during the study period; 8. Male patients must agree to use appropriate contraceptive methods during the study period; 9. Have not used bedaquiline, linezolid, delamanid, pramylam, or have used for less than one month. If the usage time exceeds one month, drug sensitivity results are required to confirm sensitivity to the above drugs
Exclusion criteria
Exclusion criteria: 1. Those who failed to complete the treatment and follow-up as per the research protocol; 2. Those who participated in any clinical trial within 3 months before screening; 3. Those with a history of allergy to nitroimidazole drugs, bedaquiline, and linezolid; 4. Those who used any drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes within 30 days before administration (including but not limited to quinidine, tyramine, ketoconazole, fluconazole, testosterone, quinine, progesterone, methyldopa, phenpropazine, amitriptyline, benzphetamine, doxorubicin, colistin, erythromycin, cocaine, furananilide, cimetidine, dextromethorphan, codeine); 5. Severe pulmonary tuberculosis and extrapulmonary tuberculosis (including disseminated pulmonary tuberculosis through blood, digestive system tuberculosis, urinary and reproductive system tuberculosis, bone and joint tuberculosis, tuberculous meningitis, etc.); 6. Silicosis, pulmonary fibrosis or other evidence of severe pulmonary diseases (excluding tuberculosis); 7. Chronic obstructive pulmonary disease or asthma; 8. Any clinically relevant comorbidities or liver damage characterized by serum creatinine level >= 1.5xULN, or liver injury characterized by ALT and/or AST levels >= 3×ULN and/or GGT levels >= 3×ULN; glycated hemoglobin not exceeding 7%; 9. Those with a history of alcohol abuse, or those who were unwilling to stop drinking 24 hours before the start of the study until the end of the study; 10. Those with concurrent diseases of the liver, kidneys, metabolism, autoimmune system, nervous system, mental health, blood system, malignant tumors, or long-term use of immunosuppressants; 11. History of drug abuse; 12. Those with the following characteristics at screening (based on the measured values and readings of electrocardiogram at the research center): 1) The QT/QTc interval is significantly prolonged, such as when QTcF (Fridericia correction) or QTcB (Bazett correction) interval is > 450 ms at screening; 2) Have a history of causing torsades de pointes ventricular tachycardia, such as heart failure, hypokalemia, long QT syndrome, etc.; 3) Have used any drugs known to prolong QTc interval within 30 days before administration (including but not limited to amiodarone, bepridil, chloroquine, chlorpromazine, cimetidine, cyclobenzaprine, clarithromycin, diphenazine, doxepin, fluphenazine, erythromycin, salicylfluoramine, haloperidol, ibutilide, levamisole, methadone, measamine, pimozide, procaine, quinine, sotalol, spironolactone, thiiazine); 4) The researcher judges that there are any clinically significant electrocardiogram abnormalities; 13. Neurological disorders, mental disorders, or epilepsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| conversion rate of sputum culture; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of good response;Proportion of patients with negative sputum culture;Incidence rate of adverse events; | — |
Countries
China
Contacts
Public ContactGao Mengqiu
Beijing Chest Hospital Affiliated to Capital Medical University
Outcome results
None listed