CClinicalTrials.gg
Sign In
Active, not recruitingNCT06081361INSPIRE-CODAUpdated Apr 1, 2025

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

A Phase 3 interventional study of Bedaquiline and Delamanid in Pulmonary Tuberculosis and Rifampicin-resistant Tuberculosis, sponsored by Beijing Chest Hospital. Active, not recruiting at 39 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Beijing Chest Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Pulmonary Tuberculosis
  • Rifampicin-resistant Tuberculosis

Keywords

  • tuberculosis
  • Rifampicin-resistant
  • short regimen
  • contezolid
  • delamanid
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's planned enrollment of 186 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Beijing Chest Hospital is the lead sponsor of 31 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18y and \<70y when signing informed consent;
  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

Exclusion criteria:

  1. 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;
  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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
186 participants (estimated)

Study arms

  • Experimental
    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

    Drug: Bedaquiline · Drug: Delamanid · Drug: Contezolid · Drug: Levofloxacin · Drug: Moxifloxacin · Drug: Clofazimine

  • Active comparator
    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

    Drug: Bedaquiline · Drug: Levofloxacin · Drug: Moxifloxacin · Drug: Clofazimine · Drug: Linezolid · Drug: Cycloserine · Drug: Prothionamide · Drug: Pyrazinamide · Drug: Para-Aminosalicylic Acid · Drug: Ethambutol

Interventions

  • DrugBedaquiline

    Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week

    Also known as: BDQ

  • DrugDelamanid

    Oral, 100mg bid

    Also known as: DLM

  • DrugContezolid

    Oral, 800mg bid

    Also known as: CZD

  • DrugLevofloxacin

    Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg

    Also known as: LFX

  • DrugMoxifloxacin

    Oral, 400mg qd

    Also known as: MFX

  • DrugClofazimine

    Oral, 100mg qd

    Also known as: CFZ

  • DrugLinezolid

    Oral, 600mg qd

    Also known as: LZD

  • DrugCycloserine

    Oral, 250mg bid

    Also known as: CS

  • DrugProthionamide

    Oral, 600mg qd for weight \<50kg, 600-800mg qd for weight ≥50kg

    Also known as: Pto

  • DrugPyrazinamide

    Oral, 1500mg qd for weight \<50kg, 1750mg qd for weight ≥50kg

    Also known as: PZA

  • DrugPara-Aminosalicylic Acid

    8000mg qd for weight \<50kg, 10000mg qd for weight ≥50kg

    Also known as: PAS

  • DrugEthambutol

    750mg qd for weight \<50kg, 1000mg qd for weight ≥50kg

    Also known as: EMB

06

What researchers measure

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.

    Time frame: from randomization to 24 months after

Secondary outcomes

  1. Unfavourable outcome rate at 24 months after randomization

    Including 1. Death; 2. Treatment failure 3. Lost-to-follow-up 4. Treatment Discontinuation 5. Ttreatment prolonging 6. Still on treatment at the end of follow up 7. Recurrence

    Time frame: from randomization to 24 months after

  2. 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

    Time frame: from randomization to 24 months after

  3. 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

    Time frame: from randomization to 24 months after

Other outcomes

  1. Contezolid plasma concentration

    To build the population PK model of contezolid with steady-state plasma concentration, measured by blood samples taken at four time points around one administration: ≤15min before and 1h±15min, 2h±15min, 3h±15min after. The index adiministration should be in 7d±3d after the first dose of contezolid.

    Time frame: 7d±3d after the first dose of contezolid

07

Study locations

39 sites
  • Beijing Chest Hospital affiliated to Capital Medical University
    Beijing, Beijing 101149, 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
  • Changsha Central Hospital
    Changsha, 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
  • Anhui Chest Hospital
    Hefei, China
  • Second People's Hospital of Hohhot
    Hohhot, China
  • Jiamusi Infectious Disease Hospital
    Jiamusi, China
  • Jiamusi Tumor 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
  • Shandong public health clinical center
    Shandong, 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
  • Second People's Hospital of Weifang
    Weifang, China
  • Wuhan Institute For Tuberculosis Control
    Wuhan, China
  • Xi'an Chest Hospital
    Xi'an, China
  • First Affiliated Hospital of Xiamen Medical University
    Xiamen, China
  • The First Affiliated Hospital of Xinxiang Medical University
    Xinxiang, China
  • Henan Provincial Chest Hospital
    Zhengzhou, China
  • Affiliated Hospital of Zunyi Medical University
    Zunyi, China
  • The 8th Affiliated Hospital of Xinjiang Medical University
    Ürümqi, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06081361
Lead sponsor
Beijing Chest Hospital
Collaborators
National Medical Center for Infectious Diseases
Responsible party
Chu naihui (Professor, Beijing Chest Hospital) — Principal investigator
First posted
Oct 13, 2023
Start date
Dec 22, 2023
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Tuberculosis→

Other studies from this sponsor

Beijing Chest Hospital

Start the discussion