Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort
NCT ID: NCT06649721
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2024-11-27
2027-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BDLL
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
bedaquiline
400 milligrams (mg) daily for 2 weeks(w), then 200mg three times a week for 22 weeks (w)
delamanid
* 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
linezolid
* 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
Levofloxacin
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
Clofazimine
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
Interventions
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bedaquiline
400 milligrams (mg) daily for 2 weeks(w), then 200mg three times a week for 22 weeks (w)
delamanid
* 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
linezolid
* 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
Levofloxacin
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
Clofazimine
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
12 Years
ALL
No
Sponsors
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Beijing Chest Hospital
OTHER
Huashan Hospital
OTHER
Responsible Party
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Wen-hong Zhang
Head of Infectious Disease Department
Locations
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Anhui Chest Hospital
Hefei, Anhui, China
The 8th Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Fourth People's Hospital of Nanning
Nanning, Guangxi, China
Liupanshui Third People's Hospital
Liupanshui, Guizhou, China
Hebei Chest Hospital
Shijiazhuang, Hebei, China
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
Infectious Disease Hospital of Heilongjiang Province
Harbin, Heilongjiang, China
Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, China
Harbin Chest Hospital
Harbin, Helongjiang, China
Luoyang Center Hospital
Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Chest Hospital
Zhengzhou, Henan, China
Henan Infectious Disease Hospital
Zhengzhou, Henan, China
Wuhan Pulmonary Hospital，Wuhan Tuberculosis Prevention and Control Institute
Wuhan, Hubei, China
Changsha Central Hospital
Changsha, Hunan, China
Hulunbuir Infectious Disease Hospital
Hulunbuir, Inner Mongolia, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
Jiangxi Chest Hospital
Nanchang, Jiangxi, China
Infectious Disease Hospital of Changchun
Changchun, Jilin, China
Jilin Tuberculosis Hospital
Jilin, Jilin, China
Shenyang Chest Hospital
Shenyang, Liaoning, China
Xi'an Chest Hospital
Xi'an, Shaanxi, China
Shandong Public Health Clinical Center, Shandong University
Jinan, Shandong, China
Linyi People Hospital
Linyi, Shandong, China
Qingdao Chest Hospital
Qingdao, Shandong, China
Weifang No.2 People's Hospital
Weifang, Shandong, China
Yantai Qishan Hospital
Yantai, Shandong, China
Shanxi Medical University Affiliated Chest Hospital
Taiyuan, Shanxi, China
Public Health Clinical Center of Chengdu
Chengdu, Sichuan, China
Tianjin Haihe Hospital
Tianjin, Tianjin Municipality, China
Wenzhou Central Hospital
Wenzhou, Zhejiang, China
Beijing Chest Hospital
Beijing, , China
Huashan Hospital
Shanghai, , China
Countries
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Other Identifiers
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INSPIRE-BDLL
Identifier Type: -
Identifier Source: org_study_id
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