A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China (PROSPECT)
Tuberculosis, Multidrug-Resistant
About this trial
This is an interventional treatment trial for Tuberculosis, Multidrug-Resistant
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Beijing Chest HospitalRecruiting
- The Eighth Medical Center of PLA General HospitalRecruiting
- Changsha Central HospitalRecruiting
- Public health clinical medical center of ChengduRecruiting
- Chongqing Public Health Medical CenterRecruiting
- The Pulmonary Hospital of Fuzhou in Fujian Province(The tuberculosis control and prevention Hospital of Fuzhou in Fujian Province)Recruiting
- Guiyang Public Health Clinical CenterRecruiting
- Anhui Chest HospitalRecruiting
- Infectious Disease Hospital of Heilongjiang ProvinceRecruiting
- Jiamusi Tumor Hospital
- Jiangxi Chest Hospital
- Shandong public health clinical centerRecruiting
- Shanghai Pulmonary HospitalRecruiting
- Shenyang Chest HospitalRecruiting
- Wuhan Pulmonary HospitalRecruiting
- Xi'an Chest HospitalRecruiting
- The First Affiliated Hospital of Xinxiang Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Bedaquiline-containing Short-course Regimen (SCR)
Non-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.
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.