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.
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
- Conditions the study is for
- Drug-resistant Tuberculosis, Pulmonary Tuberculosis, Rifampin-resistant Tuberculosis
- 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
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.
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- 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
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 group | Role | What they receive |
|---|---|---|
| BDLL | Experimental | 6-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.
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,
- . Cured: complete at least 80% of total required dose per protocol, with negative culture results of last two sputum samples (collected 14 days apart) ;
- . 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)
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
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
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.
- First posted21 Oct 2024
- Study start27 Nov 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-resistant 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chest Hospital
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
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