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

  • STATUS
    Recruiting
  • End date
    Aug 8, 2025
  • participants needed
    212
  • sponsor
    Beijing Chest Hospital
Updated on 15 July 2022

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.

Details
Condition Tuberculosis, Multidrug-Resistant
Treatment pyrazinamide, levofloxacin, bedaquiline, linezolid, Clofazimine, Cycloserine, Protionamide
Clinical Study IdentifierNCT05306223
SponsorBeijing Chest Hospital
Last Modified on15 July 2022

Eligibility

Yes No Not Sure

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
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