NCT06081361Active, not recruitingPhase 3
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis:Contezolid, Delamanid and Bedaquiline Cohort
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- First submitted
- 27 Sept 2023
- Start date
- 22 Dec 2023
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Beijing Chest Hospital
- Diseases
- Tuberculosis
- NCT number
- NCT06081361
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 186
- From 22 Dec 2023 to the primary completion date, 1 Oct 2026
- 39 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
- 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;
- 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;
Other illness
- 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;
- 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;
Lab values
- Chronic hepatitis with HBsAg, HBeAg and anti-HBC antibody positive, or HBV-DNA\>1000 CPs/mL with rising ALT/AST;
- 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
Other
- Being considered unlikely to survive for more than 6 months by investigator;
- BMI \< 17kg/m2
- Positive in pregnancy test or known pregnancy, breastfeeding, or plan to become pregnant during or within 6 months after the study treatment;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (39)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Chest Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The 8th Medical Center of Chinese Pla General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Changsha Central Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Hunan Province Chest Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chongqing Public Heath Treatment Center Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Dalian Public Health Center Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Fuzhou Pulmonary Hospital of Fujian Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Guangzhou Chest Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Heilongjiang Province center for tuberculosis Control and Prevention Coordinator of this site? Confirm its status | Haerbin | China | Unknown status |
| Second Affiliated Hospital of Hainan Medical University Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Hangzhou Red Cross Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Chest Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Anhui Chest Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Second People's Hospital of Hohhot Coordinator of this site? Confirm its status | Hohhot | China | Unknown status |
| Infectious Disease Hospital of Hulunbuir Coordinator of this site? Confirm its status | Hulunbuir | China | Unknown status |
| Jiamusi Infectious Disease Hospital Coordinator of this site? Confirm its status | Jiamusi | China | Unknown status |
| Jiamusi Tumor Hospital Coordinator of this site? Confirm its status | Jiamusi | China | Unknown status |
| Jilin Tuberculosis Hospital Coordinator of this site? Confirm its status | Jilin City | China | Unknown status |
| People's Hospital of Linyi Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| Second Hospital of Nanjing Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Guangxi Chest Hospital Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Fourth People's Hospital of Nanning Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Qingdao Chest Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shandong public health clinical center Coordinator of this site? Confirm its status | Shandong | China | Unknown status |
| National Medical Center for Infectious Disease Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Affiliated Hospital of Shaoxing University Coordinator of this site? Confirm its status | Shaoxing | China | Unknown status |
| Shenyang Chest Hospital Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Shijiazhuang Fifth Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Hebei Chest Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Taiyuan Fourth People's Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Haihe Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The 8th Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Second People's Hospital of Weifang Coordinator of this site? Confirm its status | Weifang | China | Unknown status |
| Wuhan Institute For Tuberculosis Control Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| First Affiliated Hospital of Xiamen Medical University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Xi'an Chest Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Henan Provincial Chest Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Affiliated Hospital of Zunyi Medical University Coordinator of this site? Confirm its status | Zunyi | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.