Status:
ACTIVE_NOT_RECRUITING
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort
Lead Sponsor:
Beijing Chest Hospital
Collaborating Sponsors:
National Medical Center for Infectious Diseases
Conditions:
Pulmonary Tuberculosis
Rifampicin-resistant Tuberculosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥18y and \<70y when signing informed consent;
- 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:
- 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;
- History of alcohol or drug abuse that the study is considered have negative impact on the well-being of the participant by investigator;
- HIV positive;
- Chronic hepatitis with HBsAg, HBeAg and anti-HBC antibody positive, or HBV-DNA\>1000 CPs/mL with rising ALT/AST;
- Allergic to or known hypersensitive to any of study drugs;
- Extensive (or advanced) pulmonary TB disease: presence of bilateral cavitary disease or extensive parenchymal damage on chest radiography;
- Hematogenous disseminated pulmonary tuberculosis and serious extrapulmonary tuberculosis (such as tuberculosis in digestive system, urogenital system, osteoarticular tuberculosis, tuberculous meningitis);
- 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;
- Previous or current optic nerve disorder that may progress or deteriorate during the study by investigator's consideration;
- 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;
- Being considered unlikely to survive for more than 6 months by investigator;
- BMI \< 17kg/m2
- May need surgical procedures based on the evaluation of pulmonary lesions;
- May continuous use prohibited concomitant medications that is considered not suitable for the study by investigator;
- Positive in pregnancy test or known pregnancy, breastfeeding, or plan to become pregnant during or within 6 months after the study treatment;
- 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
Exclusion
Key Trial Info
Start Date :
December 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT06081361
Start Date
December 22 2023
End Date
December 31 2026
Last Update
April 1 2025
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 101149
2
Changsha Central Hospital
Changsha, China, China
3
Anhui Chest Hospital
Hefei, China, China
4
Jiamusi Tumor Hospital
Jiamusi, China, China