A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

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

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.

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