Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort
INSPIRE-CODA
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
1 other identifier
interventional
186
1 country
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2023
Typical duration for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedStudy Start
First participant enrolled
December 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 1, 2025
March 1, 2025
2.8 years
September 27, 2023
March 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Unfavourable outcome rate at 24 months after randomization
from randomization to 24 months after
Time to culture conversion
from randomization to 24 months after
Grade 3 or higher adverse event rate
from randomization to 24 months after
Other Outcomes (1)
Contezolid plasma concentration
7d±3d after the first dose of contezolid
Study Arms (2)
Short-Term Regimen
EXPERIMENTALIntervention 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
Standard Regimen
ACTIVE COMPARATORIntervention 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
Interventions
Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week
Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg
Oral, 600mg qd for weight \<50kg, 600-800mg qd for weight ≥50kg
Oral, 1500mg qd for weight \<50kg, 1750mg qd for weight ≥50kg
8000mg qd for weight \<50kg, 10000mg qd for weight ≥50kg
750mg qd for weight \<50kg, 1000mg qd for weight ≥50kg
Eligibility Criteria
You may qualify if:
- Age ≥18y and \<70y when signing informed consent;
- Initial or re-treatment for pulmonary tuberculosis with:
- \) 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.
You may not qualify if:
- 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;
- 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;
- Chronic hepatitis with HBsAg, HBeAg and anti-HBC antibody positive, or HBV-DNA\>1000 CPs/mL with rising ALT/AST;
- 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;
- 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;
- Being considered unlikely to survive for more than 6 months by investigator;
- BMI \< 17kg/m2
- 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;
- Positive in pregnancy test or known pregnancy, breastfeeding, or plan to become pregnant during or within 6 months after the study treatment;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 101149, 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, 050000, China
Harbin Chest Hospital
Harbin, Heilongjiang, 150000, China
Infectious Disease Hospital of Hulunbuir
Hulunbuir, Inner Mongolia, China
Qingdao Chest Hospital
Qingdao, Shandong, 266000, China
Taiyuan Fourth People's Hospital
Taiyuan, Shanxi, 030000, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 27, 2023
First Posted
October 13, 2023
Study Start
December 22, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 1, 2025
Record last verified: 2025-03