Sudapyridine (WX-081) in RR-TB Patients (WISH)
Rifampicin-resistant Tuberculosis
About this trial
This is an interventional treatment trial for Rifampicin-resistant Tuberculosis
Eligibility Criteria
Inclusion Criteria: • Body mass index (BMI) and body weight of subjects: 15.0≤BMI≤28.0 kg/m2, and 40kg≤ body weight ≤90kg; For clinically diagnosed patients with tuberculosis whose drug sensitivity test has proved to be at least resistant to rifampicin, phenotypic or molecular drug sensitivity test results within 3 months before the subject signs informed consent can be accepted; Direct sputum smear positive for acid-fast bacilli (AFB at least 1+); Willing to discontinue all previous anti-tuberculosis drugs and accept a 7-day washout period; Non-lactating and pregnant women who agree to use contraception throughout the treatment; Or the male patient's spouse agrees to use contraception throughout the treatment. Exclusion Criteria: • Allergic to any study drug or its ingredients; A history of alcohol dependence or drug abuse; With hematogenous disseminated pulmonary tuberculosis or extrapulmonary tuberculosis; Drug susceptibility test before screening showed resistance to more than 4 of the 8 antituberculosis drugs in this study; Have taken Bedaquiline before; HIV-positive patients; Laboratory obvious abnormalities; A history of pointy torsion ventricular tachycardia or cardiac risk factors for pointy torsion ventricular tachycardia; Repeated QTcF intervals > 450ms; Clinically significant ventricular arrhythmias that may require medical or surgical treatment; Documented cardiovascular diseases; Peripheral neuropathy CTCAE grade 3 or grade 4; Grade 1 or grade 2 neuropathy that the investigator believes is likely to progress/worsen over the course of the study; optic neuritis; Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.
Sites / Locations
- Beijing Chest Hospital affiliated to Capital Medical University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sudapyridine arm
Bedaquiline arm