A Multicenter, Randomized, Open-Label Study To Evaluate The Efficacy And Safety Of A Contezolid, Delamanid and Bedaquiline-Containing Short Regimen For The Treatment Of Rifampicin-Resistant Pulmonary Tuberculosis

BJCH-202301

The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are: * Is the efficacy of short regimen non-inferior to standard regimen? * Is the short regimen safe enough to replace the standard regimen? Participants will: * Be given with either short or standard regimen for RR-TB treatment * Be asked to complete the scheduled visit as planned.

2023-12-22

2026-10-01

2026-12-31

Recruiting

Early phase I

186

Inclusion criteria: 1. Age ≥18y and \<70y when signing informed consent; 2. Initial or re-treatment for pulmonary tuberculosis with: 1) MTB positive in sputum or bronchoalveolar lavage fluid culture at or within 3 months before screening, or MTB positive in molecular test at or within 3 months before screening, and; 2) recorded Rifampicin-resistance at or before screening; 3. Imaging (Chest X-ray or CT scan) proved pulmonary tuberculosis within 1 year before screening; 4. Never used BDQ, DLM or CZD, or the accumulative duration of any of the treatment is not more than 2 weeks 5. For women in childbearing age, negative in pregnancy test and effective contraceptive measures throughout study is required; 6. For men, effective contraceptive measures is required; 7. Willing to participate the study and sign informed consent. Exclusion criteria: 1. The participant will be excluded by investigator based on the medical history or concomitant diseases such as serious metabolic disease, cardiovascular disease, hepatobiliary disease, renal disease, autoimmune disease, neuropsychiatric disorders, hematological disease, malignant neoplastic disease and so on; or the study will have negative impact on the well-being of the participant, or the participant is considered unable to complete the evaluation by investigator; 2. History of alcohol or drug abuse that the study is considered have negative impact on the well-being of the participant by investigator; 3. HIV positive; 4. Chronic hepatitis with HBsAg, HBeAg and anti-HBC antibody positive, or HBV-DNA\>1000 CPs/mL with rising ALT/AST; 5. Allergic to or known hypersensitive to any of study drugs; 6. Extensive (or advanced) pulmonary TB disease: presence of bilateral cavitary disease or extensive parenchymal damage on chest radiography; 7. Hematogenous disseminated pulmonary tuberculosis and serious extrapulmonary tuberculosis (such as tuberculosis in digestive system, urogenital system, osteoarticular tuberculosis, tuberculous meningitis); 8. With any of following risk factors for cardiovascular disease: 1) history of arrhythmia and on consequential treatment; 2) QTcF\>500ms on ECG; 3) history of ventricular arrhythmia; 4) torsade de pointe with heart failure, hypokalemia or familial long Q-T syndrome; 5) other possible risk factor for arrythmia; 9. Previous or current optic nerve disorder that may progress or deteriorate during the study by investigator's consideration; 10. Was enrolled within 2 months before screening, or currently in other studies; except for those who participating observational study or in the post-treatment period; 11. Being considered unlikely to survive for more than 6 months by investigator; 12. BMI \< 17kg/m2 13. May need surgical procedures based on the evaluation of pulmonary lesions; 14. May continuous use prohibited concomitant medications that is considered not suitable for the study by investigator; 15. Positive in pregnancy test or known pregnancy, breastfeeding, or plan to become pregnant during or within 6 months after the study treatment; 16. Abnormal laboratory test results: 1) Plasma potassium lower than lower limit of normal (LLN); 2) Hb \< 8.0 g/dL； 3) platelet count \<75,000/mm3； 4) WBC count\<3000/mm3； 5）AST/ALT \>3×ULN； 6）creatinine\>2×ULN；7）total bilirubin\>2×ULN, or \>1.5×ULN，with abnormal AST or ALT; 8) Albumin \< 30g/L

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 186, 'type': 'ESTIMATED'}}

2024-03-15