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

• Status: Not yet recruiting
• Trial end date: 2025-08-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Chest Hospital
• Treatments: Bedaquiline; Clofazimine; Cycloserine; Levofloxacin; Linezolid; Ofloxacin; Prothionamide; Pyrazinamide

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