Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort
NCT ID: NCT06081361
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
186 participants
INTERVENTIONAL
2023-12-22
2026-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short-Term Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
* For those sensitive to FQs: BDQ DLM CZD LFX(MFX) for 6 months
* For those resistant to FQs: BDQ DLM CZD CFZ for 6 months
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
Standard Regimen
Intervention will be determined based on Fluoroquinolones(FQs) resistance.
* For those sensitive to FQs: BDQ LZD LFX(MFX) CS CFZ regimen for 6 months, then LFX(MFX) CS CFZ for 12 months
* For those resistant to FQs: LFX(MFX) will be replaced by Pto, PZA, PAS or EMB
Bedaquiline
Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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National Medical Center for Infectious Diseases
UNKNOWN
Beijing Chest Hospital
OTHER
Responsible Party
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Chu naihui
Professor
Locations
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Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Changsha Central Hospital
Changsha, China, China
Anhui Chest Hospital
Hefei, China, China
Jiamusi Tumor Hospital
Jiamusi, China, China
Shandong public health clinical center
Shandong, China, China
Xi'an Chest Hospital
Xi'an, China, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China, China
Hebei Chest Hospital
Shijiazhuang, Hebei, China
Harbin Chest Hospital
Harbin, Heilongjiang, China
Infectious Disease Hospital of Hulunbuir
Hulunbuir, Inner Mongolia, China
Qingdao Chest Hospital
Qingdao, Shandong, China
Taiyuan Fourth People's Hospital
Taiyuan, Shanxi, China
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, , 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
Countries
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Other Identifiers
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BJCH-202301
Identifier Type: -
Identifier Source: org_study_id
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