Rifampicin-resistant tuberculosis
Conditions
Interventions
Linezolid group:FQ-S therapeutic regimen 6LFX(MFX) BDQ LZD(CS)CFZ/12 LFX(MFX) LZD(CS) CFZ
FQ-R therapeutic regimen :6BDQ LZD CS CFZ/14 LZD CS CFZ.
therapeutic regimen
contizolamide group:FQ-S therapeutic regimen 6LFX(MFX) BDQ CZD(CS)CFZ/12 LFX(MFX) CZD(CS) CFZ
FQ-R therapeutic regimen :6BDQ CZD CS CFZ/14 CZD CS CFZ.
therapeutic regimen
Sponsors
Beijing Chest Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-65 years old, male or female 2.Weight =40?, BMI = 17 ?/? 3.Rifampicin-resistant pulmonary tuberculosis (TB) patients with fluoroquinolone resistance or intolerance were diagnosed after molecular biology and/or phenotypic drug susceptibility tests and sputum culture results were positive for acid-fast bacilli within 60 days 4.No previous treatment with Bedaquinoline, contezolid, or linezolid 5.For those of childbearing age, consent to continue using contraception throughout treatmen 6.Subjects (or their legal representatives/guardians) understand the study procedures and content, sign informed consent, and are willing to participate in the study and comply with treatment and follow-up requirements.
Exclusion criteria
Exclusion criteria: 1.Hematogenous disseminated tuberculosis and severe extrapulmonary tuberculosis (including digestive system tuberculosis, urogenital system tuberculosis, osteoarticular tuberculosis, tuberculous meningitis, etc.) 2.Allergic to oxazolidinones or use of monoamine oxidase inhibitors 2 weeks before enrollment 3.Severe renal insufficiency (creatinine clearance (CrCl) less than 30 mL/min) or impaired liver function (ALT and/or AST levels 3 times the upper limit of the laboratory reference value) 4.Hemoglobin 450 ms 7: 3) History of ventricular arrhythmia 4) tip torsion ventricular tachycardia, associated with the following risk factors, including heart failure, hypokalemia, familial long QT syndrome 5) Other heart conditions that may increase the subject's arrhythmia. Life expectancy =6 months 6.ife expectancy less than 6 months 7.Karnofsky score <60 ; 8.Pregnant or lactating women 9.Unable to take oral medication 10. HIV positive or AIDS patients 11.Known peripheral neuropathy of grade 3 or higher 12.Have participated in, or are currently participating in, another clinical study within 2 months prior to screening 13.Patients who were deemed unlikely to complete regular follow-up visits to the study center due to travel restrictions, drug or alcohol abuse, or other reasons 14. Patients with any pre-existing laboratory abnormalities or other undefined clinical diagnosis may be adversely affected by participation in the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| conversion rate of sputum culture;body weight change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chest imaging changes;The time during treatment when sputum culture becomes persistently negative;Good response rate at 6 months of treatment; | — |
Countries
China
Contacts
Public ContactGaomengqiu
Beijing Chest Hospital Affiliated to Capital Medical University
Outcome results
None listed