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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

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Beijing Chest Hospital affiliated to Capital Medical University
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BeijingChinaUnknown status
The 8th Medical Center of Chinese Pla General Hospital
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BeijingChinaUnknown status
Changsha Central Hospital
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ChangshaChinaUnknown status
Hunan Province Chest Hospital
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ChangshaChinaUnknown status
Chongqing Public Heath Treatment Center
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ChongqingChinaUnknown status
Dalian Public Health Center
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DalianChinaUnknown status
Fuzhou Pulmonary Hospital of Fujian
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FuzhouChinaUnknown status
Guangzhou Chest Hospital
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GuangzhouChinaUnknown status
Heilongjiang Province center for tuberculosis Control and Prevention
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HaerbinChinaUnknown status
Second Affiliated Hospital of Hainan Medical University
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HaikouChinaUnknown status
Hangzhou Red Cross Hospital
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HangzhouChinaUnknown status
Harbin Chest Hospital
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HarbinChinaUnknown status
Anhui Chest Hospital
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HefeiChinaUnknown status
Second People's Hospital of Hohhot
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HohhotChinaUnknown status
Infectious Disease Hospital of Hulunbuir
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HulunbuirChinaUnknown status
Jiamusi Infectious Disease Hospital
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JiamusiChinaUnknown status
Jiamusi Tumor Hospital
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JiamusiChinaUnknown status
Jilin Tuberculosis Hospital
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Jilin CityChinaUnknown status
People's Hospital of Linyi
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LinyiChinaUnknown status
Second Hospital of Nanjing
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NanjingChinaUnknown status
Guangxi Chest Hospital
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NanningChinaUnknown status
Fourth People's Hospital of Nanning
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NanningChinaUnknown status
Qingdao Chest Hospital
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QingdaoChinaUnknown status
Shandong public health clinical center
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ShandongChinaUnknown status
National Medical Center for Infectious Disease
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ShanghaiChinaUnknown status
Affiliated Hospital of Shaoxing University
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ShaoxingChinaUnknown status
Shenyang Chest Hospital
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ShenyangChinaUnknown status
Shijiazhuang Fifth Hospital
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ShijiazhuangChinaUnknown status
Hebei Chest Hospital
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ShijiazhuangChinaUnknown status
Taiyuan Fourth People's Hospital
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TaiyuanChinaUnknown status
Tianjin Haihe Hospital
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TianjinChinaUnknown status
The 8th Affiliated Hospital of Xinjiang Medical University
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ÜrümqiChinaUnknown status
Second People's Hospital of Weifang
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WeifangChinaUnknown status
Wuhan Institute For Tuberculosis Control
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WuhanChinaUnknown status
First Affiliated Hospital of Xiamen Medical University
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XiamenChinaUnknown status
Xi'an Chest Hospital
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Xi'anChinaUnknown status
The First Affiliated Hospital of Xinxiang Medical University
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XinxiangChinaUnknown status
Henan Provincial Chest Hospital
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ZhengzhouChinaUnknown status
Affiliated Hospital of Zunyi Medical University
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ZunyiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.