A Phase 3 Study Assessing the Safety and Efficacy of Bedaquiline Plus PA-824 Plus Linezolid in Subjects With Drug Resistant Pulmonary Tuberculosis

Study Director
Dan Everitt
Start Date
2 / 2015
Trial Phase
Phase III
Trial Status
all patients enrolled
Current Enrollment
Target Enrollment

August 14, 2019 - FDA Approval of Pretomanid in combination with bedaquiline and linezolid for treating a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant or nonresponsive multidrug resistant pulmonary TB.

June 6, 2019 - FDA advisory committee meeting

NDA filed with FDA

Open Label Phase 3 study - Enrollment ended November 15, 2017.  Interim results presented at UNION conference in Guadalajara 2017 and at CROI 2017. Transition to ZeNix with first patient screened 11/16/2017.

Experimental: Bedaquiline + PA-824 + Linezolid

bedaquiline 400 mg once daily for 2 weeks then 200mg 3 times per week plus PA-824 200mg once daily plus linezolid 600mg twice daily.
Primary Outcome Measures:
  • Incidence of bacteriologic failure or relapse or clinical failure through follow up until 24 months after the end of treatment. [ Time Frame: Treatment Period: Day 1, Week 1, 2, 4, 6, 8, 12, 16, 20, 26, 30, 34, 39 Follow Up: Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 ]

    Bacteriologic failure: During the treatment period, failure to attain culture conversion to negative.

    Bacteriologic relapse: During the follow-up period, failure to maintain culture conversion to negative status in culture, with culture conversion to positive status with a Mycobacterium tuberculosis (M.tb.) strain that is genetically identical to the infecting strain at baseline.

    Clinical failure: A change from protocol-specified TB treatment due to treatment failure, retreatment for TB during follow up, or TB-related death.

    Note: Culture conversion requires at least 2 consecutive culture negative/positive samples at least 21 days apart.

    Subjects who are documented at a visit as unable to produce sputum and who are clinically considered to be responding well to treatment will be considered to be culture negative at that visit.

Developer Associations
Compound Associations