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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06081361
Other study ID # BJCH-202301
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 22, 2023
Est. completion date December 31, 2026

Study information

Verified date March 2024
Source Beijing Chest Hospital
Contact Wenjuan Nie, M.D.
Phone 010-89509331
Email 94642975@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 186
Est. completion date December 31, 2026
Est. primary completion date October 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Drug:
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

Locations

Country Name City State
China Beijing Chest Hospital affiliated to Capital Medical University Beijing Beijing
China The 8th Medical Center of Chinese Pla General Hospital Beijing
China Changsha Central Hospital Changsha
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 Harbin Chest Hospital Harbin Heilongjiang
China Anhui Chest Hospital Hefei
China Second People's Hospital of Hohhot Hohhot
China Infectious Disease Hospital of Hulunbuir Hulunbuir Inner Mongolia
China Jiamusi Infectious Disease Hospital Jiamusi
China Jiamusi Tumor Hospital Jiamusi
China Jilin Tuberculosis Hospital Jilin
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 Qingdao Chest Hospital Qingdao Shandong
China Shandong public health clinical center Shandong
China National Medical Center for Infectious Disease Shanghai
China Affiliated Hospital of Shaoxing University Shaoxing
China Shenyang Chest Hospital Shenyang
China Hebei Chest Hospital Shijiazhuang Hebei
China Shijiazhuang Fifth Hospital Shijiazhuang
China Taiyuan Fourth People's Hospital Taiyuan Shanxi
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 Xi'an Chest Hospital Xi'an
China First Affiliated Hospital of Xiamen Medical University Xiamen
China The First Affiliated Hospital of Xinxiang Medical University Xinxiang
China Henan Provincial Chest Hospital Zhengzhou
China Affiliated Hospital of Zunyi Medical University Zunyi

Sponsors (2)

Lead Sponsor Collaborator
Beijing Chest Hospital National Medical Center for Infectious Diseases

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Contezolid plasma concentration To build the population PK model of contezolid with steady-state plasma concentration, measured by blood samples taken at four time points around one administration: =15min before and 1h±15min, 2h±15min, 3h±15min after. The index adiministration should be in 7d±3d after the first dose of contezolid. 7d±3d after the first dose of contezolid
Primary Favourable outcome rate at 24 months after randomization The proportion of participants with a favourable outcome. A participant's outcome will be classified as favourable if their last two sputum culture results are negative unless they have previously been classified as unfavourable. These two cultures must be taken on separate visits (with =28d interval); the latest of which not being earlier than month 23 from randomization. from randomization to 24 months after
Secondary Unfavourable outcome rate at 24 months after randomization Including
Death;
Treatment failure
Lost-to-follow-up
Treatment Discontinuation
Ttreatment prolonging
Still on treatment at the end of follow up
Recurrence
from randomization to 24 months after
Secondary Time to culture conversion Time from treatment initiation to first negative result in sputum culture confirmed by two consecutive cultures with an interval of =28d from randomization to 24 months after
Secondary Grade 3 or higher adverse event rate Proportion of participants experiencing at least one grade 3 or higher adverse event, or serious adverse event defined by the Division of AIDS severity criteria for adverse events from randomization to 24 months after
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