A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
NCT ID: NCT05306223
Last Updated: 2023-01-18
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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UNKNOWN
PHASE4
212 participants
INTERVENTIONAL
2022-05-10
2025-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bedaquiline-containing Short-course Regimen (SCR)
Participants will receive an oral dose of bedaquiline 400 milligrams (mg) once daily for first 2 weeks followed by bedaquiline 200 mg thrice a week for 22 weeks (with at least 48 hours between doses) in combination with oral doses of levofloxacin (LFX) up to 1000 mg (weight-based), cycloserine (CS) up to 750 mg (weight-based), clofazimine (CFZ) 100 mg daily for 40 weeks and linezolid \[LZD\] 600 mg daily for at least 24 weeks . If a participant is still sputum culture-positive for Mycobacterium tuberculosis by Week 16, bedaquiline treatment will be extended from Week 24 to Week 40.
Bedaquiline
Bedaquiline uncoated tablets will be administered orally.
Levofloxacin
Levofloxacin filmcoated will be administered orally
Linezolid
Linezolid tablets will be administered orally
Cycloserine
Cycloserine capsules will be administered orally.
Clofazimine
Clofazimine capsules will be administered orally.
Non-bedaquiline-containing Short-course Regimen (SCR)
Participants will receive oral doses of LFX up to 1000 mg (weight-based), CS up to 750 mg (weight-based), CFZ 100 mg, Pyrazinamide (PZA) up to 2000 mg (weight-based), Protionamide (PTO) up to 800 mg (weight-based) daily for first 16 weeks and LZD 600 mg daily for at least 24 weeks.
Levofloxacin
Levofloxacin filmcoated will be administered orally
Linezolid
Linezolid tablets will be administered orally
Cycloserine
Cycloserine capsules will be administered orally.
Clofazimine
Clofazimine capsules will be administered orally.
Pyrazinamide
Pyrazinamide tablets will be administered orally.
Protionamide
Protionamide enteric-coated tablets will be administered orally.
Interventions
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Bedaquiline
Bedaquiline uncoated tablets will be administered orally.
Levofloxacin
Levofloxacin filmcoated will be administered orally
Linezolid
Linezolid tablets will be administered orally
Cycloserine
Cycloserine capsules will be administered orally.
Clofazimine
Clofazimine capsules will be administered orally.
Pyrazinamide
Pyrazinamide tablets will be administered orally.
Protionamide
Protionamide enteric-coated tablets will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has microbiological confirmation of rifampicin resistance by GeneXpert and to isoniazid (INH) via molecular drug-susceptibility testing (DST) showing katG mutation
* Has a chest imaging result compatible with a diagnosis of pulmonary Tuberculosis (TB)
* Agrees to use effective contraception during the 40-week study treatment phase. A female participant must be: of nonchildbearing potential; of childbearing potential and practicing effective methods of contraception during the 40-week study treatment phase
* Is willing to undergo human immunodeficiency virus (HIV) testing
Exclusion Criteria
* Has prior exposure to at least 1 second-line drug in the regimen for at least 4 weeks
* Has any grade 3 or 4 laboratory abnormality as confirmed by a clinical expert
* Has a known allergy or intolerance to bedaquiline or other drugs in the regimen
* Is infected with a strain of nontuberculous mycobacteria
* Is HIV-positive
18 Years
65 Years
ALL
No
Sponsors
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Beijing Chest Hospital
OTHER
Responsible Party
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Gao Mengqiu
Director of Department of Tuberculosis
Principal Investigators
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Mengqiu Gao
Role: PRINCIPAL_INVESTIGATOR
Beijing Chest Hospital
Locations
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Beijing Chest Hospital
Beijing, , China
The Eighth Medical Center of PLA General Hospital
Beijing, , China
Changsha Central Hospital
Changsha, , China
Public health clinical medical center of Chengdu
Chengdu, , China
Chongqing Public Health Medical Center
Chongqing, , China
The Pulmonary Hospital of Fuzhou in Fujian Province（The tuberculosis control and prevention Hospital of Fuzhou in Fujian Province）
Fuzhou, , China
Guiyang Public Health Clinical Center
Guiyang, , China
Anhui Chest Hospital
Hefei, , China
Infectious Disease Hospital of Heilongjiang Province
Heilongjiang, , China
Jiamusi Tumor Hospital
Jiamusi, , China
Jiangxi Chest Hospital
Jiangxi, , China
Shandong public health clinical center
Shandong, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Shenyang Chest Hospital
Shenyang, , China
Wuhan Pulmonary Hospital
Wuhan, , China
Xi'an Chest Hospital
Xi'an, , China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, , China
Countries
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Central Contacts
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Facility Contacts
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Mengqiu Gao
Role: primary
Huiru An
Role: primary
Yi Pei
Role: primary
Guihui Wu
Role: primary
Xiaofeng Yan
Role: primary
Xiaohong Chen
Role: primary
Zhongfeng Huang
Role: primary
Hua Wang
Role: primary
Long Jin
Role: primary
Xiujie Li
Role: primary
Yuqing Wu
Role: primary
Yu Xiong
Role: primary
Wei Sha
Role: primary
Lian Shi
Role: primary
Juan Du
Role: primary
Fei Ren
Role: primary
Junwei Cui
Role: primary
References
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Gao J, Gao M, Du J, Pang Y, Mao G, Lounis N, Bakare N, Jiang Y, Zhan Y, Liu Y, Li L; Trial Team. A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT. Trials. 2024 Apr 1;25(1):227. doi: 10.1186/s13063-024-07946-9.
Other Identifiers
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TMC207TBC4006
Identifier Type: OTHER
Identifier Source: secondary_id
TMC207TBC4006
Identifier Type: -
Identifier Source: org_study_id
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