A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China
PROSPECT
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
1 other identifier
interventional
212
1 country
17
Brief Summary
The purpose of this study is to evaluate efficacy and safety of an oral bedaquiline-containing multidrug-resistant tuberculosis (MDR-TB) short-course regimen (SCR) compared to an oral SCR not including bedaquiline at the end of treatment in participants with pulmonary MDR-TB in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2022
Typical duration for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 1, 2022
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2025
CompletedJanuary 18, 2023
January 1, 2023
3.2 years
March 23, 2022
January 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with a Favorable Treatment Outcome at the End of Treatment
Percentage of participants with a favorable treatment outcome at the end of treatment will be reported. A participant's outcome will be classified as favorable if their last 3 culture results by the end of treatment are negative unless they have previously been classified as unfavorable. These 3 cultures must be taken on separate visits; the latest of which being no more than 8 weeks prior to the end of treatment.
At the end of treatment (Week 40)
Secondary Outcomes (8)
Percentage of Participants with a Favorable Treatment Outcome at 48 Weeks Post the End of Treatment
At 48 weeks post the end of treatment (Week 88)
Percentage of Participants Achieving Treatment Success at the end of Treatment
At the end of treatment (Week 40)
Percentage of Participants with a Modified Favorable Treatment Outcome at the end of Treatment and at 48 Weeks Post end of Treatment
At the end of treatment (Week 40) and at 48 weeks post end of treatment (Week 88)
Percentage of Participants Experiencing All-cause Mortality
Up to Week 88
Percentage of Participants Experiencing Grade 3 or Greater Treatment-emergent Adverse Events (TEAEs) During Study Treatment and Follow-up
During study treatment and follow-up (From Week 1 up to Week 88)
- +3 more secondary outcomes
Study Arms (2)
Bedaquiline-containing Short-course Regimen (SCR)
EXPERIMENTALParticipants 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.
Non-bedaquiline-containing Short-course Regimen (SCR)
EXPERIMENTALParticipants 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.
Interventions
Bedaquiline uncoated tablets will be administered orally.
Levofloxacin filmcoated will be administered orally
Linezolid tablets will be administered orally
Cycloserine capsules will be administered orally.
Clofazimine capsules will be administered orally.
Pyrazinamide tablets will be administered orally.
Protionamide enteric-coated tablets will be administered orally.
Eligibility Criteria
You may qualify if:
- Has a positive sputum Mycobacterium tuberculosis culture from a test performed at screening
- 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
You may not qualify if:
- Has received prior treatment with bedaquiline
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Beijing Chest Hospital
Beijing, 101149, 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
Related Publications (1)
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.
PMID: 38561815DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mengqiu Gao
Beijing Chest Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Tuberculosis
Study Record Dates
First Submitted
March 23, 2022
First Posted
April 1, 2022
Study Start
May 10, 2022
Primary Completion
August 8, 2025
Study Completion
August 8, 2025
Last Updated
January 18, 2023
Record last verified: 2023-01