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Clinical Trials in China / NCT06081361
Active, not recruiting Phase 3

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis:Contezolid, Delamanid and Bedaquiline Cohort

NCT06081361 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Chest Hospital
Phase
Phase 3
Started
2023-12-22
Last updated
2025-04-01

Condition(s) studied

Pulmonary TuberculosisRifampicin-resistant Tuberculosis

Investigational drug(s) / intervention(s)

BedaquilineDelamanidContezolidLevofloxacinMoxifloxacinClofazimineLinezolidCycloserineProthionamidePyrazinamidePara-Aminosalicylic AcidEthambutol

Bedaquiline: Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week

Delamanid: Oral, 100mg bid

Contezolid: Oral, 800mg bid

Levofloxacin: Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg

Moxifloxacin: Oral, 400mg qd

Clofazimine: Oral, 100mg qd

Linezolid: Oral, 600mg qd

Cycloserine: Oral, 250mg bid

Prothionamide: Oral, 600mg qd for weight \<50kg, 600-800mg qd for weight ≥50kg

Pyrazinamide: Oral, 1500mg qd for weight \<50kg, 1750mg qd for weight ≥50kg

Para-Aminosalicylic Acid: 8000mg qd for weight \<50kg, 10000mg qd for weight ≥50kg

Ethambutol: 750mg qd for weight \<50kg, 1000mg qd for weight ≥50kg

Study 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 (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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Beijing Chest Hospital affiliated to Capital Medical University Beijing Beijing Municipality
Changsha Central Hospital Changsha China
Anhui Chest Hospital Hefei China
Jiamusi Tumor Hospital Jiamusi China
Shandong public health clinical center Shandong China
Xi'an Chest Hospital Xi'an China
The First Affiliated Hospital of Xinxiang Medical University Xinxiang China
Hebei Chest Hospital Shijiazhuang Hebei
Harbin Chest Hospital Harbin Heilongjiang
Infectious Disease Hospital of Hulunbuir Hulunbuir Inner Mongolia
Qingdao Chest Hospital Qingdao Shandong
Taiyuan Fourth People's Hospital Taiyuan Shanxi
The 8th Medical Center of Chinese Pla General Hospital Beijing China
Hunan Province Chest Hospital Changsha China
Chongqing Public Heath Treatment Center Chongqing China
Dalian Public Health Center Dalian China
Fuzhou Pulmonary Hospital of Fujian Fuzhou China
Guangzhou Chest Hospital Guangzhou China
Heilongjiang Province center for tuberculosis Control and Prevention Haerbin China
Second Affiliated Hospital of Hainan Medical University Haikou China
Hangzhou Red Cross Hospital Hangzhou China
Second People's Hospital of Hohhot Hohhot China
Jiamusi Infectious Disease Hospital Jiamusi China
Jilin Tuberculosis Hospital Jilin City China
People's Hospital of Linyi Linyi China
Second Hospital of Nanjing Nanjing China
Fourth People's Hospital of Nanning Nanning China
Guangxi Chest Hospital Nanning China
National Medical Center for Infectious Disease Shanghai China
Affiliated Hospital of Shaoxing University Shaoxing China
Shenyang Chest Hospital Shenyang China
Shijiazhuang Fifth Hospital Shijiazhuang China
Tianjin Haihe Hospital Tianjin China
The 8th Affiliated Hospital of Xinjiang Medical University Ürümqi China
Second People's Hospital of Weifang Weifang China
Wuhan Institute For Tuberculosis Control Wuhan China
First Affiliated Hospital of Xiamen Medical University Xiamen China
Henan Provincial Chest Hospital Zhengzhou China
Affiliated Hospital of Zunyi Medical University Zunyi China

More Beijing Chest Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06081361 on ClinicalTrials.gov ↗ ← All trials in China