Pulmonary TuberculosisPhase 3INSPIRE-CODANCT06081361
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort
A Phase 3 study testing Bedaquiline, Delamanid and Contezolid in people with Pulmonary Tuberculosis and Rifampicin-resistant Tuberculosis, run by Beijing Chest Hospital at 39 sites in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Tuberculosis, Rifampicin-resistant Tuberculosis
- What is being tested?
- Bedaquiline, Delamanid and Contezolid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 39 sitesChina
- Study dates
- 22 Dec 2023to 31 Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
China39 sites
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 101149
The 8th Medical Center of Chinese Pla General Hospital
Beijing
Changsha Central Hospital
Changsha, China
Hunan Province Chest Hospital
Changsha
Chongqing Public Heath Treatment Center
Chongqing
Dalian Public Health Center
Dalian
Fuzhou Pulmonary Hospital of Fujian
Fuzhou
Guangzhou Chest Hospital
Guangzhou
Heilongjiang Province center for tuberculosis Control and Prevention
Haerbin
Second Affiliated Hospital of Hainan Medical University
Haikou
Hangzhou Red Cross Hospital
Hangzhou
Harbin Chest Hospital
Harbin, Heilongjiang, 150000
Anhui Chest Hospital
Hefei, China
Second People's Hospital of Hohhot
Hohhot
Infectious Disease Hospital of Hulunbuir
Hulunbuir, Inner Mongolia
Jiamusi Tumor Hospital
Jiamusi, China
Jiamusi Infectious Disease Hospital
Jiamusi
Jilin Tuberculosis Hospital
Jilin City
People's Hospital of Linyi
Linyi
Second Hospital of Nanjing
Nanjing
Fourth People's Hospital of Nanning
Nanning
Guangxi Chest Hospital
Nanning
Qingdao Chest Hospital
Qingdao, Shandong, 266000
Shandong public health clinical center
Shandong, China
National Medical Center for Infectious Disease
Shanghai
Affiliated Hospital of Shaoxing University
Shaoxing
Shenyang Chest Hospital
Shenyang
Hebei Chest Hospital
Shijiazhuang, Hebei, 050000
Shijiazhuang Fifth Hospital
Shijiazhuang
Taiyuan Fourth People's Hospital
Taiyuan, Shanxi, 030000
Tianjin Haihe Hospital
Tianjin
The 8th Affiliated Hospital of Xinjiang Medical University
Ürümqi
Second People's Hospital of Weifang
Weifang
Wuhan Institute For Tuberculosis Control
Wuhan
Xi'an Chest Hospital
Xi'an, China
First Affiliated Hospital of Xiamen Medical University
Xiamen
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Henan Provincial Chest Hospital
Zhengzhou
Affiliated Hospital of Zunyi Medical University
Zunyi
About this study
Official title: 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
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.
- Being tested
- Bedaquiline, Delamanid, Contezolid, Levofloxacin, Moxifloxacin
- Keywords
- tuberculosis, Rifampicin-resistant, short regimen, contezolid, delamanid
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BedaquilineDrug
Also called BDQ
Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week
DelamanidDrug
Also called DLM
Oral, 100mg bid
ContezolidDrug
Also called CZD
Oral, 800mg bid
LevofloxacinDrug
Also called LFX
Oral, 400mg qd for weight <50kg, 600-750mg qd for weight ≥50kg
MoxifloxacinDrug
Also called MFX
Oral, 400mg qd
ClofazimineDrug
Also called CFZ
Oral, 100mg qd
LinezolidDrug
Also called LZD
Oral, 600mg qd
CycloserineDrug
Also called CS
Oral, 250mg bid
ProthionamideDrug
Also called Pto
Oral, 600mg qd for weight <50kg, 600-800mg qd for weight ≥50kg
PyrazinamideDrug
Also called PZA
Oral, 1500mg qd for weight <50kg, 1750mg qd for weight ≥50kg
Para-Aminosalicylic AcidDrug
Also called PAS
8000mg qd for weight <50kg, 10000mg qd for weight ≥50kg
EthambutolDrug
Also called EMB
750mg qd for weight <50kg, 1000mg qd for weight ≥50kg
| Study group | Role | What they receive |
|---|---|---|
| Short-Term Regimen | Experimental | 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 Receives: Drug: Bedaquiline; Drug: Delamanid; Drug: Contezolid; Drug: Levofloxacin; Drug: Moxifloxacin; Drug: Clofazimine |
| Standard Regimen | Active comparator | 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 Receives: Drug: Bedaquiline; Drug: Levofloxacin; Drug: Moxifloxacin; Drug: Clofazimine; Drug: Linezolid; Drug: Cycloserine; Drug: Prothionamide; Drug: Pyrazinamide; Drug: Para-Aminosalicylic Acid; Drug: Ethambutol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from randomization to 24 months after
Secondary outcomes (3)
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
Measured: from randomization to 24 months after
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
Measured: from randomization to 24 months after
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
Measured: from randomization to 24 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start22 Dec 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Infectious Diseases
- Responsible party
- Principal investigator, Chu naihui, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081361
- Sponsor's protocol ID
- BJCH-202301
- Acronym
- INSPIRE-CODA
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No