AzTrials
AzTrials

Drug-resistant TuberculosisPhase 3INSPIRE-BDLLNCT06649721

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

A Phase 3 study testing bedaquiline, delamanid and linezolid in people with Drug-resistant Tuberculosis and Pulmonary Tuberculosis, run by Huashan Hospital at 34 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), or BDLLfxC… Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
bedaquiline, delamanid and linezolid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
34 sitesChina
Study dates
27 Nov 2024to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants are willing to sign informed consent of this trial, those without capacity for civil conduct need their legal guardian to sign
  • Participants (and their legal guardian if applicable) are willing to cooperate to complete all trial procedures
  • Male or female, 12 years or older, weight ≥ 30kg
  • Confirmed pulmonary tuberculosis with resistance to rifampin by phenotypic or genotypic susceptibility testing within 3 months, and must be re-confirmed by sputum culture sampled at trial inclusion
  • Women with childbearing potential should not be pregnant, confirmed by a volunteered negative pregnancy test, and are willing to use effective contraceptive method from giving consent to 3 months after study treatment
  • Men with childbearing potential must be willing to use condom or other effective contraceptive methods to avoid their sex partners from being pregnant
  • Women in breastfeeding period must be willing to discontinue breastfeeding from giving consent to 3 months after study treatment
  • Participants are willing to take HIV test, and willing to take appropriate antiretroviral therapy if positive

Who cannot join

  • Previously use of Bedaquiline or Delamanid for at least 28 days
  • Concomitant hematogenous disseminated tuberculosis, or severe pulmonary tuberculosis in investigator's opinion (including tuberculosis of the digestive system, osteoarticular tuberculosis or tuberculous meningitis)
  • Currently using any drug that has been prohibited in the protocol
  • History of allergic action to any of the study drugs
  • Currently participating in any other clinical trials
  • Cardiovascular risk at screening: (1) QTcF more than 480 milliseconds (ms); (2) History of clinically significant arrythmia, and at investigator's opinion, participation in this study will increase the risk; (3) Decompensated heart failure; (4) Grade 3 high blood pressure and the goals of treatment have not been reached; (5) Abnormal thyroid function; (6) Abnormal serum Ca, Mg or K level; (7) Other conditions with cardiovascular risks in investigator's opinion.
Show all 11Show fewer
  • History of optic neuropathy or peripheral neuropathy, and the investigator considers that the condition may progress or deteriorate by participating in the study, or inappropriate to participate
  • Hepatic disorders at screening: (1) Active viral hepatitis: HBsAg positive or HBV DNA >1000 CPs/mL, with elevated AST or ALT or HCV RNA positive; (2) Decompensated cirrhosis
  • Renal disorders at screening: (1) Unstable or rapidly progressive renal disease; (2) Moderate / severe renal disfunction or end-stage renal disease (eGFR< 60 mL/min/1.73 m2); (3) Serum creatinine ≥133 μmol/L(1.5 mg/mL) in men, or ≥124 μmol/L (1.4 mg/mL) in women
  • Other abnormal laboratory test: (1) Hemoglobin < 8.0g/dL; (2) Platelet <75,000/mm3; (3) Absolute neutrophil count <1000/mm3; (4) Aspartate transaminase (AST) or alanine aminotransferase (ALT) >3×upper limit of normal (ULN); (5) Total bilirubin (TBil) >2×ULN, or >1.5×ULN together with abnormal AST or ALT; (6) Albumin <30g/L
  • The investigator considers that the participant is not able to complete the study process, or the participation is not safe.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

China34 sites

  • The 8th Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Beijing Chest Hospital

    Beijing

  • Infectious Disease Hospital of Changchun

    Changchun, Jilin

  • Changsha Central Hospital

    Changsha, Hunan

  • Public Health Clinical Center of Chengdu

    Chengdu, Sichuan

  • Infectious Disease Hospital of Heilongjiang Province

    Harbin, Heilongjiang

  • Harbin Chest Hospital

    Harbin, Helongjiang

  • Anhui Chest Hospital

    Hefei, Anhui

  • Hulunbuir Infectious Disease Hospital

    Hulunbuir, Inner Mongolia

  • Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)

    Jiamusi, Heilongjiang

  • Jilin Tuberculosis Hospital

    Jilin City, Jilin

  • Shandong Public Health Clinical Center, Shandong University

    Jinan, Shandong

  • Linyi People Hospital

    Linyi, Shandong

  • Liupanshui Third People's Hospital

    Liupanshui, Guizhou

  • Luoyang Center Hospital

    Luoyang, Henan

  • Jiangxi Chest Hospital

    Nanchang, Jiangxi

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu

  • The Fourth People's Hospital of Nanning

    Nanning, Guangxi

  • Qingdao Chest Hospital

    Qingdao, Shandong

  • Huashan Hospital

    Shanghai

  • Shenyang Chest Hospital

    Shenyang, Liaoning

  • Hebei Chest Hospital

    Shijiazhuang, Hebei

  • The Fifth Hospital of Shijiazhuang

    Shijiazhuang, Hebei

  • Shanxi Medical University Affiliated Chest Hospital

    Taiyuan, Shanxi

  • Tianjin Haihe Hospital

    Tianjin, Tianjin Municipality

  • Weifang No.2 People's Hospital

    Weifang, Shandong

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang

  • Wuhan Pulmonary Hospital，Wuhan Tuberculosis Prevention and Control Institute

    Wuhan, Hubei

  • Xi'an Chest Hospital

    Xi'an, Shaanxi

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

  • Yantai Qishan Hospital

    Yantai, Shandong

  • Henan Chest Hospital

    Zhengzhou, Henan

  • Henan Infectious Disease Hospital

    Zhengzhou, Henan

Other trials in China

About this study

This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), or BDLLfxC regimen, to treat rifampin-resistant pulmonary tuberculosis (RR-TB) in Chinese teenagers and adults (aged 12 years or above). The main questions it aims to answer are:

  • Is BDLLfxC regimen effective to treat RR-TB in Chinese participants?
  • Is BDLLfxC regimen safe in Chinese RR-TB participants? Participants will take BDLLfxC regimen to treat their RR-TB. There will be no additional hospital visits, laboratory tests or radiological examinations other than routine clinical practice.
Being tested
bedaquiline, delamanid, linezolid, Levofloxacin, Clofazimine
Keywords
Drug-resistant tuberculosis, BDLL, Chinese Population, Short regimen
Medical subject headings
Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bedaquilineDrug

    Also called BDQ, B

    400 milligrams (mg) daily for 2 weeks(w), then 200mg three times a week for 22 weeks (w)

  • delamanidDrug

    Also called DLM, D

    • for participants weighing up to 33.9 kilograms (kg): 50mg two times a day for 24w
    • for participants weighing 34kg or above: 100mg two times a day for 8w, then 200mg daily for 16w

  • linezolidDrug

    Also called LZD, L

    • for participants weighing up to 33.9kg: 450mg daily;
    • for participants weighing 34kg or above: 600mg daily; for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w

  • LevofloxacinDrug

    Also called LFX

    Only for participants with confirmed fluoroquinolone-susceptible TB or unknown fluoroquinolone susceptibility:

    • for participants weighing up to 33.9kg: 500mg daily
    • for participants weighing 34kg to 49.9kg: 750 daily
    • for participants weighing 50kg or above: 1000mg daily for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w

  • ClofazimineDrug

    Also called CFZ, C

    Only for participants with confirmed fluoroquinolone-resistant TB or unknown fluoroquinolone susceptibility:

    100mg daily, for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w

Study groups in NCT06649721
Study groupRoleWhat they receive
BDLLExperimental6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), as known as BDLLfxC or BDLL regimen
Receives: Drug: bedaquiline; Drug: delamanid; Drug: linezolid; Drug: Levofloxacin; Drug: Clofazimine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with favorable outcomes in both treatment and follow-up period

    Favorable outcome in treatment period (up to 28 weeks after start of treatment): a participant's outcome will be defined as "favorable" if it meets any of the following below and has not been defined as "unfavorable" before,

    1. . Cured: complete at least 80% of total required dose per protocol, with negative culture results of last two sputum samples (collected 14 days apart) ;
    2. . Treatment completed: complete at least 80% of total required dose per protocol, with NO negative culture results of last two sputum samples (collected 14 days apart); Favorable outcome in follow-up period (from end of treatment to 72 weeks after start of treatment): a participant's outcome will be defined as "favorable" if it meets any of the following below and has not been defined as "unfavorable" before, (1). Cured: sputum culture negative at 72 weeks from start of treatment; (2). Culture negative when last seen: loss to follow-up before 72 weeks, with negative sputum culture when last seen.

    Measured: Up to 72 weeks after start of treatment

Secondary outcomes (3)

  1. Proportion of participants with grade 3 or 4 adverse effect

    Adverse effect will be graded using Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.

    Measured: Up to 72 weeks after start of treatment

  2. Proportion of participants with favorable outcomes in treatment period, follow-up period and prolonged follow-up period, respectively

    The definitions of favorable outcome in treatment and follow-up period are as described in primary outcome. Favorable outcome in prolonged follow-up period (from end of treatment to 108 weeks after start of treatment): a participant's outcome will be defined as "favorable" if it meets any of the following below and has not been defined as "unfavorable" before, (1). Cured: sputum culture negative at 108 weeks from start of treatment; (2). Culture negative when last seen: loss to follow-up before 108 weeks, with negative sputum culture when last seen.

    Measured: Up to 108 weeks after start of treatment

  3. Time to culture conversion

    Time from start of treatment to the first time that obtained two consecutive negative sputum culture results, and the sputum samples must be collected 14 days apart. The date when first sputum sample is collected will be recorded as the date for culture conversion.

    Measured: Up to 72 weeks after start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2024
  2. Study start27 Nov 2024
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06649721
Sponsor's protocol ID
INSPIRE-BDLL
Acronym
INSPIRE-BDLL
Status last verified
Aug 2025
First submitted
16 Oct 2024
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bedaquiline, delamanid and linezolid in people with Drug-resistant Tuberculosis and Pulmonary Tuberculosis, run by Huashan Hospital at 34 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with favorable outcomes in both treatment and follow-up period (time frame: Up to 72 weeks after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06649721.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in