Pulmonary tuberculosis
Conditions
Interventions
The experimental group uses the BDCzdLfxC regimen.:Dose: 400 mg, once every 12 hours
The control group adopts the BDLLfxC regimen.:600 mg per dose, once daily
Sponsors
Shandong Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Male or female, aged >=14 years old; (2) Patients diagnosed with RR-TB; Sputum samples that were positive for Mycobacterium tuberculosis culture within 3 months before screening, or that were confirmed as Mycobacterium tuberculosis by molecular biology testing within 3 months before screening or at the time of screening; They were resistant to rifampicin. (3) Pulmonary tuberculosis confirmed by chest imaging examination (chest X-ray or CT scan) within 1 year before screening; (4) Sputum smear (bronchoscope lavage fluid) during the screening period was positive for acid-fast bacilli, culture or molecular biology; (5) Voluntarily participated in the study and signed the informed consent; (6) Women of childbearing age who had a negative pregnancy test and agreed to use a highly effective contraceptive method during the study; Male patients had to consent to use an appropriate method of contraception.
Exclusion criteria
Exclusion criteria: (1) According to the investigator's judgment, he or she was not suitable to participate in the study according to his or her past medical history or current combined diseases or medication, including but not limited to serious metabolic diseases, cardiovascular and cerebrovascular diseases, hepatobiliary diseases, renal diseases, autoimmune diseases, neurological diseases, psychiatric diseases, hematological diseases, and malignant tumors; Or the investigator believes that participating in the study will harm the health of the subject and the subject cannot complete the corresponding assessment; (2) If the participant has a history of alcohol dependence or drug abuse, if the investigator believes that participating in the study will harm the participant's health, or if the participant believes that the participant cannot comply with the protocol-specified visits and assessments; (3) According to the judgment of the investigator, the expected survival time is not more than 6 months; (4) HIV positive; (5) Chronic active hepatitis, hepatitis B surface antigen (HBsAg), hepatitis Be antigen (HBeAg) and hepatitis B core antibody (anti-HBc) positive, or HBV-DNA>1000cps/mL, with elevated ALT/AST; (6) Allergic history or known hypersensitivity reaction history to oxazolidinones and drugs of treatment regimen; (7) Body mass index (BMI) 500 ms on ECG; 3) history of ventricular arrhythmia; 4) Torsades de pointes with risk factors including heart failure, hypokalemia, and familial long QT syndrome; 5) other cardiac diseases that may increase the occurrence of arrhythmia in the subjects. (12) Patients with a history of optic neuropathy or peripheral neuropathy who, in the opinion of the investigator, might progress/worsen during the study or were not suitable for the study; (13) Women who had a positive pregnancy test at screening or who were known to be pregnant, breastfeeding, or planning to become pregnant during the study or within 6 months after discontinuation of treatment. Men who plan to become pregnant during the study or within 6 months of stopping treatment; (14) Diagnostic and laboratory abnormalities: 1) serum potassium below the lower limit of normal; 2) hemoglobin level 3*ULN; 6) creatinine >2*ULN; 7) Total bilirubin >2*ULN, or >1.5*ULN, combined with other liver enzyme abnormalities, albumin <30g/L;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CT chest ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram ; | — |
Countries
China
Contacts
Public ContactXiong Yu
Shandong Public Health Clinical Center
Outcome results
None listed