Trial

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
in data analysis
Current Enrollment
109
Target Enrollment
200
Overview

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.

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